Electrosurgical, Cutting & Coagulation & Accessories
FDA product code GEI · Class II (moderate risk) · 21 CFR 878.4400 · General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
2,316510(k) clearances
0PMA approvals
594recalls
Manufacturers
- Arthrocare Corp. 86
- Valleylab, Inc. 69
- Conmedcorp 43
- Covidien LLC 40
- Megadyne Medical Products, Inc. 32
- Aaron Medical Industries 27
- Conmed Corporation 25
- Erbe USA, Inc. 25
- Ethicon Endo-Surgery, Inc. 25
- Aspen Laboratories, Inc. 24
- Applied Medical Resources Corp 21
- Bovie Medical Corporation 21
- Oratec Interventions, Inc. 21
- Gyrus Acmi, Inc. 20
- New Deantronics Taiwan , Ltd. 19
- Aesculap, Inc. 18
- Thermage, Inc. 17
- Barrx Medical, Incorporated 16
- Valley Forge Scientific Corp. 16
- Somnus Medical Technologies, Inc. 16
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
| K253634 | CoolSeal Generator® (CSL-200-90)GEI · Traditional | Hologic, Inc. | 06/17/2026SE |
| K261833 | NEUROMARK System (NMK00301)GEI · Special | Neurent Medical , Ltd. | 06/16/2026SE |
| K253165 | LAP-iX2NGEI · Traditional | Sejong Medical Co., Ltd. | 06/09/2026SE |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation SystemGEI · Traditional | Medtronic Sofamor Danek USA, Inc. | 06/05/2026SE |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)GEI · Traditional | F Care Systems USA, LLC | 06/02/2026SE |
| K253803 | MILAN SystemGEI · Traditional | Lumenis Be, Ltd. | 06/02/2026SE |
| K261202 | ENTire IRE SystemGEI · Special | Entire Medical , Ltd. | 05/29/2026SE |
| K252833 | VIVA combo RF SystemGEI · Traditional | Starmed Co., Ltd. | 05/26/2026SE |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)GEI · Traditional | Lagis Enterprise Co., Ltd. | 05/20/2026SE |
| K260522 | RhinAer+ StylusGEI · Traditional | Aerin Medical, Inc. | 05/18/2026SE |
| K253917 | ARION ARC SystemGEI · Traditional | Plasma Surgical, Inc. | 04/10/2026SE |
| K253777 | Ascblue (8010)GEI · Traditional | Ascblue Corporation | 04/10/2026SE |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional…GEI · Traditional | Zhejiang shuyou Surgical Instrument Co., Ltd. | 04/07/2026SE |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)GEI · Traditional | Hironic Co., Ltd. | 04/06/2026SE |
| K253405 | Prana SystemGEI · Traditional | Prana Surgical | 04/01/2026SE |
| K254122 | FLOW FLEXTEND Wand (72290039)GEI · Traditional | ArthroCare Corporation | 03/30/2026SE |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)GEI · Traditional | Aventix Medical, Inc. | 03/27/2026SE |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254)GEI · Traditional | ArthroCare Corporation | 03/25/2026SE |
| K253750 | BTL-785NEHGEI · Traditional | BTL Industries, Inc. | 03/17/2026SE |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)GEI · Traditional | Gyrus Acmi, Inc. | 03/02/2026SE |
| K260287 | SP Electrocautery Device (SP20)GEI · Special | Single Pass, Inc. | 02/24/2026SE |
| K251813 | CURIS II RF Generator (REF 360100-05)GEI · Traditional | Sutter Medizintechnik GmbH | 02/11/2026SE |
| K251836 | Dermatrix DuoGEI · Traditional | Shenzhen Gsd Technology Co., Ltd. | 02/06/2026SE |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)GEI · Special | Shenzhen Peninsula Medical Group | 01/30/2026SE |
| K254220 | Reusable 3 Button Fingerswitch WandGEI · Special | Soniquence, LLC | 01/27/2026SE |
| K251435 | InbellaIgnite RF SystemGEI · Traditional | Inbella Medical, Inc. | 01/27/2026SE |
| K251254 | Ignite RF SystemGEI · Traditional | InMode , Ltd. | 01/15/2026SE |
| K251996 | ENTire IRE SystemGEI · Traditional | Entire Medical , Ltd. | 01/14/2026SE |
| K251988 | Boston iFace (Boston iFace)GEI · Traditional | Boston Aesthetics, Inc. | 01/12/2026SE |
| K253915 | MOVIVA® Hybrid Ablation ProbeGEI · Traditional | Erbe Elektromedizin GmbH | 12/18/2025SE |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)GEI · Traditional | F Care Systems USA, LLC | 11/24/2025SE |
| K251566 | TS-RF Generator (STS10)GEI · Traditional | Starmed Co., Ltd. | 11/17/2025SE |
| K252845 | Venus Nova (FP-2001)GEI · Traditional | Venus Concept, Inc. | 11/06/2025SE |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion)GEI · Special | Applied Medical Resources Corp. | 11/04/2025SE |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)GEI · Traditional | Applied Medical Resources Corporation | 10/31/2025SE |
| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath FootswitchGEI · Traditional | Baylis Medical Technologies, Inc. | 10/28/2025SE |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)GEI · Traditional | Livsmed, Inc. | 10/21/2025SE |
| K250852 | CoolfaseGEI · Traditional | Asterasys Co., Ltd. | 10/16/2025SE |
| K252367 | InbellaMulti SystemGEI · Traditional | Inbella Medical, Inc. | 10/15/2025SE |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…GEI · Traditional | Olympus Medical Systems Corporation | 10/07/2025SE |
| K250688 | Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency…GEI · Traditional | Acotec Scientific Co., Ltd. | 10/07/2025SE |
| K251899 | E BlatorGEI · Traditional | New Deantronics Taiwan , Ltd. | 10/01/2025SE |
| K251334 | New Doublo 2.0GEI · Traditional | Hironic Co., Ltd. | 09/29/2025SE |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…GEI · Traditional | Olympus Winter & Ibe GmbH | 09/23/2025SE |
| K252576 | Legend X PlatformGEI · Special | Pollogen, Ltd. | 09/12/2025SE |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI · Traditional | Stryker Instruments | 09/09/2025SE |
| K250217 | AGNES UltraGEI · Traditional | Agnes Medical Co., Ltd. | 09/03/2025SE |
| K251108 | Erbe ESU Model VIO® 3n with AccessoriesGEI · Traditional | Erbe Elektromedizin GmbH | 08/29/2025SE |
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)GEI · Special | Venclose, Inc. | 08/19/2025SE |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…GEI · Traditional | Agnes Medical Co., Ltd. | 08/19/2025SE |
| K252083 | HOTWIRE System RF Generator and Footswitch (optional accessory)GEI · Traditional | Atraverse Medical, Inc. | 08/12/2025SE |
| K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T…GEI · Special | Cnc Technologies | 08/11/2025SE |
| K251327 | XerfGEI · Traditional | Lutronic Corporation | 08/11/2025SE |
| K252215 | InbellaMAX SystemGEI · Special | Inbella Medical , Ltd. | 07/25/2025SE |
| K250065 | DENSITY; DENZA; DENSITY NoirGEI · Traditional | Jeisys Medical Incorporated | 07/08/2025SE |
| K243120 | HybridAPC probeGEI · Traditional | Erbe Elektromedizin GmbH | 06/20/2025SE |
| K251235 | Electrosurgical PadsGEI · Traditional | Baisheng Medical Co., Ltd. | 06/19/2025SE |
| K242996 | EndyMed PRO MAXGEI · Traditional | Endymed Medical, Ltd. | 06/10/2025SE |
| K242907 | DELPHI SystemGEI · Traditional | CnS Medical Co., Ltd. | 06/06/2025SE |
| K250657 | gi2000 Electrosurgical GeneratorGEI · Traditional | Cintron Medical Corporation | 06/03/2025SE |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3…GEI · Traditional | Maquet Cardiovascular, LLC | 05/30/2025SE |
| K250048 | NEUROMARK System (NMK00301)GEI · Traditional | Neurent Medical , Ltd. | 05/29/2025SE |
| K243176 | BLESSING SystemGEI · Traditional | Cellah Medical Co., Ltd. | 05/16/2025SE |
| K240857 | Youmagic FLM System (YM5-U1)GEI · Traditional | We Medical Technology (Wuxi) Co., Ltd. | 05/15/2025SE |
| K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003)GEI · Traditional | Vigeon Technology Co., Ltd. | 05/09/2025SE |
| K242469 | RFMagik LiteGEI · Traditional | Agnes Medical Co., Ltd. | 04/25/2025SE |
| K250327 | OptaBlate Radiofrequency (RF) Generator SystemGEI · Special | Stryker Instruments | 04/15/2025SE |
| K242773 | Electro Lube NXTGEI · Traditional | Steris | 04/15/2025SE |
| K243451 | FiAPC plus probesGEI · Traditional | Erbe Elektromedizin GmbH | 03/21/2025SE |
| K242241 | SunnyGEI · Traditional | ShenB Co., Ltd. | 03/19/2025SE |
| K243918 | Vasoview Hemopro 3 Power SupplyGEI · Traditional | Maquet Cardiovascular, LLC | 02/26/2025SE |
| K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…GEI · Traditional | Boston Aesthetics, Inc. | 02/13/2025SE |
| K250200 | InbellaBody SystemGEI · Special | Inbella Medical, Inc. | 02/11/2025SE |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050)GEI · Special | Creo Medical, Ltd. | 02/05/2025SE |
| K250068 | Venclose digiRF Generator (VCRFG1)GEI · Special | Venclose, Inc. | 02/04/2025SE |
| K243139 | Reverso Pro SystemGEI · Traditional | Indiba S. A. U. | 01/22/2025SE |
| K240311 | JETT Medical IIGEI · Traditional | Compex, Spol, S.R.O. | 01/22/2025SE |
| K243929 | Oligio XGEI · Special | Wontech Co., Ltd. | 01/21/2025SE |
| K243067 | The ETHICON Total Energy SystemGEI · Traditional | Ethicon Endo-Surgery, LLC (A Johnson and Johnson… | 01/17/2025SE |
| K243737 | Inbella RF SystemGEI · Traditional | Inbella Medical, Inc. | 01/03/2025SE |
| K233118 | DUET-V (Model: ESK-3261DV)GEI · Traditional | Eunsung Global Corp | 01/03/2025SE |
| K243097 | RM STAR EX with RMS NeedleGEI · Traditional | Bomtech Electronics Co., Ltd. | 12/26/2024SE |
| K240975 | Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)GEI · Traditional | Beijing Taktvoll Technology Co., Ltd. | 12/23/2024SE |
| K242688 | Finiff SystemGEI · Traditional | Skingrab Co., Ltd. | 12/20/2024SE |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle…GEI · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240758 | Radiofrequency Generator System, Cura RF ElectrodeGEI · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 12/11/2024SE |
| K242630 | Aerin ConsoleGEI · Traditional | Aerin Medical, Inc. | 12/10/2024SE |
| K231216 | PotenzaGEI · Traditional | Jeisys Medical, Inc. | 12/10/2024SE |
| K240897 | CellinewGEI · Traditional | VIOL Co., Ltd. | 11/26/2024SE |
| K241157 | Secret MAX Multi-platform RF SystemGEI · Traditional | Ilooda Co,., Ltd. | 11/21/2024SE |
| K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…GEI · Traditional | Livsmed, Inc. | 11/15/2024SE |
| K242286 | Superflow Prime Treatment System (ASP-1M)GEI · Traditional | Guangzhou Aimira Innovation Technology Co, Ltd. | 11/08/2024SE |
| K241099 | Plasonic (Plasonic)GEI · Traditional | Hironic Co., Ltd. | 11/08/2024SE |
| K231287 | PotenzaGEI · Traditional | Jeisys Medical, Inc. | 11/05/2024SE |
| K243217 | Legend X Desktop SystemGEI · Traditional | Pollogen, Ltd. | 11/01/2024SE |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI · Traditional | Stryker Instruments | 10/21/2024SE |
| K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A…GEI · Traditional | Dongguan Quanding Medical Supplies Co., Ltd. | 09/25/2024SE |
| K241535 | Vybe RF IIGEI · Traditional | ShenB Co., Ltd. | 09/25/2024SE |
| K242044 | FiAPC plus probesGEI · Traditional | Erbe Elektromedizin GmbH | 08/26/2024SE |
| K241635 | da Vinci E-200 Electrosurgical GeneratorGEI · Traditional | Intuitive Surgical | 08/05/2024SE |
| K240932 | HybridTherm SystemGEI · Traditional | Erbe Elektromedizin GmbH | 08/05/2024SE |
| K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G…GEI · Traditional | Pulse Biosciences, Inc. | 08/05/2024SE |
| K241621 | Da Vinci Monopolar and Bipolar Adapters (378896)GEI · Traditional | Intuitive Surgical | 08/02/2024SE |
| K240780 | InMode RF SystemGEI · Traditional | InMode , Ltd. | 07/24/2024SE |
| K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)GEI · Traditional | Covidien, LLC | 07/12/2024SE |
| K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient…GEI · Traditional | Megadyne Medical Products, Inc. | 07/12/2024SE |
| K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20)GEI · Traditional | Wickimed (Huizhou) Medical Equipment… | 07/11/2024SE |
| K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10)…GEI · Traditional | Covidien, LLC | 07/01/2024SE |
| K240070 | Profound MatrixGEI · Traditional | Candela Corporation | 07/01/2024SE |
| K233123 | SilkroGEI · Traditional | Hironic Co., Ltd. | 06/24/2024SE |
| K240017 | InMode System with the Morpheus8 90 ApplicatorGEI · Traditional | InMode , Ltd. | 06/13/2024SE |
| K240657 | ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic…GEI · Traditional | Livsmed, Inc. | 06/06/2024SE |
| K241055 | Electro Lube NXTGEI · Traditional | Steris | 05/31/2024SE |
| K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency CatheterGEI · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 05/30/2024SE |
| K233120 | CWM-930S, Fixer DV9GEI · Traditional | Chungwoo Co., Ltd. | 05/23/2024SE |
| K233099 | GladiatorGEI · Traditional | Rohrer Aesthetics, LLC | 05/22/2024SE |
| K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…GEI · Special | Relign Corporation, Subsidiary of Zimmer Biomet | 05/08/2024SE |
| K240999 | Legend X Applicator VOGEI · Traditional | Pollogen, Ltd. | 05/08/2024SE |
| K240964 | FLOW 90? WandGEI · Special | ArthroCare Corporation | 05/08/2024SE |
| K240248 | VolnewmerGEI · Traditional | Classys, Inc. | 04/29/2024SE |
| K232805 | Kronos Electrocautery DeviceGEI · Traditional | Single Pass, Inc. | 04/25/2024SE |
| K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm…GEI · Traditional | Microline Surgical, Inc. | 04/23/2024SE |
| K233849 | BTL-499GEI · Traditional | BTL Industries, Inc. | 04/23/2024SE |
| K222958 | mJOULE RF System and AccessoriesGEI · Traditional | Sciton, Inc | 04/23/2024SE |
| K233604 | BTL-785SGEI · Traditional | BTL Industries, Inc. | 03/28/2024SE |
| K233642 | InMode RF SystemGEI · Traditional | InMode , Ltd. | 03/20/2024SE |
| K233002 | Beed 2,5, Beed 3,8GEI · Traditional | Excelsior Resources, LLC | 03/20/2024SE |
| K232301 | Define RF Microneedling SystemGEI · Traditional | Aesthetic Management Partners | 03/14/2024SE |
| K233705 | CellFX Percutaneous Electrode System (SYS3000)GEI · Traditional | Pulse Biosciences, Inc. | 03/08/2024SE |
| K232703 | Disposable Bipolar ForcepsGEI · Traditional | Jiangsu Hope Biomedical Science & Technology… | 03/06/2024SE |
| K230837 | PlazMagikGEI · Traditional | Agnes Medical Co., Ltd. | 02/29/2024SE |
| K233830 | OsteoCool 2.0 RF Ablation SystemGEI · Traditional | Medtronic Sofamor Danek USA, Inc. | 02/28/2024SE |
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…GEI · Traditional | Maquet Cardiovascular, LLC | 02/27/2024SE |
| K240313 | Oligio XGEI · Special | Wontech Co., Ltd. | 02/22/2024SE |
| K231985 | Disposable Grounding PadGEI · Traditional | Shenzhen Mecun Medical Supply Co., Ltd. | 02/16/2024SE |
| K232072 | Amica-Gen AGN-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GGEI · Traditional | H.S Hospital Service S.P.A | 02/09/2024SE |
| K234140 | VIVA combo RF System (VIVA combo RF System)GEI · Special | Starmed Co., Ltd. | 01/30/2024SE |
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes…GEI · Traditional | Sutter Medizintechnik GmbH | 01/25/2024SE |
| K231405 | Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use…GEI · Traditional | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. | 01/18/2024SE |
| K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm…GEI · Traditional | Baisheng Medical Co., Ltd. | 01/08/2024SE |
| K232992 | 10THERMAGEI · Traditional | Tentech, Inc. | 12/20/2023SE |
| K233374 | Secret ProGEI · Special | Ilooda Co,., Ltd. | 12/14/2023SE |
| K232947 | SIRA RFA Electrosurgical DeviceGEI · Special | Innoblative Designs, Inc. | 12/12/2023SE |
| K232290 | INTELLIO SHIFT SystemGEI · Traditional | ArthroCare Corporation | 12/11/2023SE |
| K231615 | Disposable Endoscopic BipolarGEI · Traditional | Jiangsu Hope Biomedical Science & Technology… | 12/05/2023SE |
| K230621 | LaproGlide Disposable Monopolar PTFE Coated Laparoscopic ProbesGEI · Traditional | Surgical Principals, Inc. | 12/01/2023SE |
| K232033 | HYBRIDknife® flexGEI · Traditional | Erbe Elektromedizin GmbH | 11/29/2023SE |
| K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…GEI · Special | Relign Corporation | 11/28/2023SE |
| K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable…GEI · Traditional | Hg Innovations, Ltd. | 11/20/2023SE |
| K233346 | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable…GEI · Traditional | Hg Innovations, Ltd. | 11/20/2023SE |
| K231012 | CoolSeal TrinityGEI · Traditional | Bolder Surgical, LLC | 11/15/2023SE |
| K233147 | PiXel8-RFGEI · Special | Rohrer Aesthetics | 10/25/2023SE |
| K231327 | POWERSEAL Sealer and DividerGEI · Traditional | Gyrus Acmi, Inc. | 10/25/2023SE |
| K222997 | VVR Generator systemGEI · Traditional | Starmed Co., Ltd. | 10/25/2023SE |
| K233185 | MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel SystemGEI · Special | C2dx, Inc. | 10/24/2023SE |
| K232223 | PlaDuo SystemGEI · Traditional | ShenB Co., Ltd. | 10/24/2023SE |
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer MarylandGEI · Traditional | Conmed Corporation | 10/23/2023SE |
| K231749 | Radio Frequency SystemGEI · Traditional | Shenzhenshi Sincoheren S&T Development Co., Ltd. | 10/19/2023SE |
| K232903 | Legend X PlatformGEI · Traditional | Pollogen, Ltd. | 10/17/2023SE |
| K231495 | The Evolve System with the Transform ApplicatorGEI · Traditional | InMode , Ltd. | 10/13/2023SE |
| K232809 | Cross Vascular RF Generator and Footswitch (optional accessory)GEI · Traditional | Cross Vascular, Inc. | 10/12/2023SE |
| K230650 | Monopolar Electrode Surgical InstrumentGEI · Traditional | Vhmed (Nantong) Co. , Ltd. | 10/12/2023SE |
| K232460 | Disposable electrosurgical pencil (MD1000)GEI · Traditional | Shenzhen Mecun Medical Supply Co., Ltd. | 10/11/2023SE |
| K232407 | Cautery Protective Actuation System (CPAS)GEI · Traditional | Safer Surgeries Medical Devices, LLC | 10/06/2023SE |
| K232763 | Electrode Handpieces (VCT, RFTV, BMDT series)GEI · Special | RF Medical Co., Ltd. | 10/04/2023SE |
| K230467 | BTL-899FGEI · Traditional | BTL Industries, Inc. | 09/21/2023SE |
| K231146 | AliTightGEI · Traditional | Alic Iotech, LLC | 09/08/2023SE |
| K221743 | Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical ElectrodesGEI · Traditional | Jiangsu Bonss Medical Technology Co., Ltd. | 09/07/2023SE |
| K223303 | Spinery RF Ablation SystemGEI · Traditional | Axon Spine Medical System | 08/30/2023SE |
| K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module…GEI · Traditional | Kirwan Surgical Products, LLC | 08/25/2023SE |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories:…GEI · Traditional | Olympus Winter & Ibe GmbH | 08/18/2023SE |
| K230663 | DensityGEI · Traditional | Jeisys Medical, Inc. | 08/14/2023SE |
| K223856 | NuEra Tight RF FamilyGEI · Traditional | Bios S.R.L. | 08/11/2023SE |
| K231126 | Eblator DeviceGEI · Traditional | E Surgical, LLC | 08/02/2023SE |
| K231790 | The InMode System with the Morpheus8 ApplicatorsGEI · Special | InMode , Ltd. | 07/20/2023SE |
| K230968 | VYBE RF Electrosurgical SystemGEI · Special | ShenB Co., Ltd. | 07/06/2023SE |
| K223135 | AblatePal Radiofrequency Ablation SystemGEI · Traditional | Compal Electronics, Inc. | 06/30/2023SE |
| K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…GEI · Traditional | ArthroCare Corporation | 06/26/2023SE |
| K231212 | da Vinci E-200 Electrosurgical GeneratorGEI · Traditional | Intuitive Surgical | 06/21/2023SE |
| K223033 | Tixel® 2 SystemGEI · Traditional | Novoxel , Ltd. | 06/21/2023SE |
| K230586 | Renuvion® Micro HandpieceGEI · Traditional | Apyx Medical Corporation | 06/09/2023SE |
| K230498 | ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional | Livsmed, Inc. | 06/05/2023SE |
| K222556 | BTL-785XGEI · Traditional | BTL Industries, Inc. | 05/31/2023SE |
| K230593 | VictanGEI · Traditional | Jiangsu Haize Medical Scientific Development… | 05/30/2023SE |
| K230432 | Single Use Bipolar ForcepsGEI · Traditional | Hg Innovations, Ltd. | 05/18/2023SE |
| K223805 | AgnesGEI · Traditional | Agnes Medical Co., Ltd. | 05/04/2023SE |
| K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation…GEI · Traditional | Conmed Corporation | 04/27/2023SE |
| K230539 | ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional | Livsmed, Inc. | 04/27/2023SE |
| K230272 | Renuvion® APR HandpieceGEI · Traditional | Apyx Medical Corporation | 04/27/2023SE |
| K230499 | ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional | Livsmed, Inc. | 04/26/2023SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3035-2026 Class II | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.…Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | Olympus Corporation of the Americas | 08/18/2026Open, Classified |
| Z-2866-2026 Class II | STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2865-2026 Class II | STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2741-2026 Class II | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI…Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an… | Maquet Cardiovascular, LLC | 06/02/2026Open, Classified |
| Z-1854-2026 Class II | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.Potential for detachment of a distal tip component of the device during use. | Olympus Corporation of the Americas | 03/23/2026Open, Classified |
| Z-1853-2026 Class II | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.Potential for detachment of a distal tip component of the device during use. | Olympus Corporation of the Americas | 03/23/2026Open, Classified |
| Z-1852-2026 Class II | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.Potential for detachment of a distal tip component of the device during use. | Olympus Corporation of the Americas | 03/23/2026Open, Classified |
| Z-1851-2026 Class II | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.Potential for detachment of a distal tip component of the device during use. | Olympus Corporation of the Americas | 03/23/2026Open, Classified |
| Z-1644-2026 Class II | Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | Olympus Corporation of the Americas | 02/25/2026Open, Classified |
| Z-1643-2026 Class II | Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | Olympus Corporation of the Americas | 02/25/2026Open, Classified |
| Z-1642-2026 Class II | Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | Olympus Corporation of the Americas | 02/25/2026Open, Classified |
| Z-1641-2026 Class II | Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | Olympus Corporation of the Americas | 02/25/2026Open, Classified |
| Z-1640-2026 Class II | Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | Olympus Corporation of the Americas | 02/25/2026Open, Classified |
| Z-1639-2026 Class II | Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name:…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | Olympus Corporation of the Americas | 02/25/2026Open, Classified |
| Z-1638-2026 Class II | Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | Olympus Corporation of the Americas | 02/25/2026Open, Classified |
| Z-0601-2026 Class II | NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook -…Tape used to secure components within packaging contains latex, despite products being labeled as… | Stryker Corporation | 10/31/2025Open, Classified |
| Z-0600-2026 Class II | NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product…Tape used to secure components within packaging contains latex, despite products being labeled as… | Stryker Corporation | 10/31/2025Open, Classified |
| Z-0599-2026 Class II | NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13…Tape used to secure components within packaging contains latex, despite products being labeled as… | Stryker Corporation | 10/31/2025Open, Classified |
| Z-0146-2026 Class II | XERF EFFECTOR 60. Electrosurgical unit.Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse… | Lutronic Corporation | 09/04/2025Open, Classified |
| Z-2638-2025 Class II | Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify…Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature… | Bard Peripheral Vascular Inc | 08/21/2025Open, Classified |
| Z-2636-2025 Class II | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW…Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled… | Maquet Cardiovascular, LLC | 08/06/2025Open, Classified |
| Z-2339-2025 Class II | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator…Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error"… | Olympus Corporation of the Americas | 07/25/2025Open, Classified |
| Z-2338-2025 Class II | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator…Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error"… | Olympus Corporation of the Americas | 07/25/2025Open, Classified |
| Z-1622-2025 Class II | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in…There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the… | Maquet Cardiovascular, LLC | 03/20/2025Open, Classified |
| Z-1577-2025 Class II | Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the…Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not… | Maquet Cardiovascular, LLC | 03/10/2025Open, Classified |
| Z-1549-2025 Class II | MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue)…Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline… | MEDLINE INDUSTRIES, LP - Northfield | 03/05/2025Open, Classified |
| Z-1548-2025 Class II | MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline…Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline… | MEDLINE INDUSTRIES, LP - Northfield | 03/05/2025Open, Classified |
| Z-1547-2025 Class II | MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number…Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline… | MEDLINE INDUSTRIES, LP - Northfield | 03/05/2025Open, Classified |
| Z-1546-2025 Class II | MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line &…Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline… | MEDLINE INDUSTRIES, LP - Northfield | 03/05/2025Open, Classified |
| Z-1139-2025 Class II | stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal…Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them… | Stryker Corporation | 01/08/2025Open, Classified |
| Z-1138-2025 Class II | stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal…Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them… | Stryker Corporation | 01/08/2025Open, Classified |
| Z-0712-2025 Class I | Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers:…Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of… | Maquet Cardiovascular, LLC | 12/09/2024Open, Classified |
| Z-0711-2025 Class I | VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000.…Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of… | Maquet Cardiovascular, LLC | 12/09/2024Open, Classified |
| Z-0807-2025 Class II | 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V…Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the… | Stryker Corporation | 12/03/2024Open, Classified |
| Z-0660-2025 Class I | Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product…Potential for the outer stainless-steel tube to break or detach. | Kirwan Surgical Products, LLC | 11/14/2024Open, Classified |
| Z-0659-2025 Class I | Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979.…Potential for the outer stainless-steel tube to break or detach. | Kirwan Surgical Products, LLC | 11/14/2024Open, Classified |
| Z-0658-2025 Class I | Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product…Potential for the outer stainless-steel tube to break or detach. | Kirwan Surgical Products, LLC | 11/14/2024Open, Classified |
| Z-0657-2025 Class I | Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The…Potential for the outer stainless-steel tube to break or detach. | Kirwan Surgical Products, LLC | 11/14/2024Open, Classified |
| Z-0656-2025 Class I | Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight.…Potential for the outer stainless-steel tube to break or detach. | Kirwan Surgical Products, LLC | 11/14/2024Open, Classified |
| Z-0655-2025 Class I | Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long.…Potential for the outer stainless-steel tube to break or detach. | Kirwan Surgical Products, LLC | 11/14/2024Open, Classified |
| Z-0654-2025 Class I | Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog…Potential for the outer stainless-steel tube to break or detach. | Kirwan Surgical Products, LLC | 11/14/2024Open, Classified |
| Z-0808-2025 Class II | Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack)…Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus… | Aerin Medical, Inc. | 11/12/2024Open, Classified |
| Z-0663-2025 Class II | Microscissor Tip (Disposable); Microline Catalog #: 3122.A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off. | Microline Surgical, Inc. | 11/05/2024Open, Classified |
| Z-0370-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile -…There is a potential for the product to activate without manual input when plugged into a power source or… | Stryker Corporation | 10/04/2024Open, Classified |
| Z-0369-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button -…There is a potential for the product to activate without manual input when plugged into a power source or… | Stryker Corporation | 10/04/2024Open, Classified |
| Z-0368-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch…There is a potential for the product to activate without manual input when plugged into a power source or… | Stryker Corporation | 10/04/2024Open, Classified |
| Z-0367-2025 Class II | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm -…There is a potential for the product to activate without manual input when plugged into a power source or… | Stryker Corporation | 10/04/2024Open, Classified |
| Z-0366-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile -…There is a potential for the product to activate without manual input when plugged into a power source or… | Stryker Corporation | 10/04/2024Open, Classified |
| Z-0365-2025 Class II | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed…There is a potential for the product to activate without manual input when plugged into a power source or… | Stryker Corporation | 10/04/2024Open, Classified |
| Z-0092-2025 Class I | VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. | Maquet Cardiovascular, LLC | 09/20/2024Open, Classified |