Laparoscope, Gynecologic (And Accessories)
FDA product code HET · Class II (moderate risk) · 21 CFR 884.1720 · Obstetrics/Gynecology
338510(k) clearances
0PMA approvals
14recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 29
- Dixon Medical, Inc. 12
- ETHICON, Inc. 11
- Marlo Surgical Technology 10
- Kli 9
- Baxter Healthcare Corp 9
- United States Surgical, A Division of Tyco Healthc 9
- Richard Wolf Medical Instruments Corp. 9
- Olympus America, Inc. 8
- Paladin Medical, Inc. 8
- Applied Medical Resources Corp 7
- Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh 6
- Olympus Medical Systems Corp. 6
- Imagyn Medical, Inc. 5
- Cook Ob/Gyn 5
- Cook Urological, Inc. 5
- Medigroup 4
- Origin Medsystems, Inc. 4
- R-Med, Inc. 4
- Gynescope Corp. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230)HET · Traditional | Precision Robotics (Hong Kong) Limited | 08/29/2025SE |
| K243821 | i-CutHET · Traditional | A.M.I. Agency For Medical Innovations GmbH | 04/25/2025SE |
| K221642 | SIRIUS Endoscope SystemHET · Traditional | Precision Robotics (Hong Kong) Limited | 12/12/2022SE |
| K210116 | Video Endoscopy System, 3D Video Endoscopy SystemHET · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 10/13/2021SE |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HET · Traditional | Olympus Medical Systems Corp. | 09/17/2021SE |
| K210104 | SurroundScope SystemHET · Traditional | 270surgical , Ltd. | 07/08/2021SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | Schoelly Fiberoptic GmbH | 03/12/2021SE |
| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
| K190744 | Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)HET · Special | Olympus Winter & Ibe GmbH | 08/29/2019SE |
| K172796 | Flex Robotic System and Flex Transabdominal DriveHET · Traditional | Medrobotics Corporation | 01/18/2018SE |
| K173111 | LAP-iX Suction IrrigationHET · Traditional | Sejong Medical Co., Ltd. | 11/28/2017SE |
| K163320 | LAP-Pump PP110HET · Traditional | W.O.M. World of Medicine GmbH | 03/21/2017SE |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/20/2015SE |
| K151011 | Visera 4K Uhd SystemHET · Traditional | Olympus Medical Systems Corp. | 10/01/2015SE |
| K131656 | Morcellex Sigma GeneratorHET · Traditional | ETHICON, Inc. | 09/27/2013SE |
| K123365 | Olympus LTF-190-10-3D, MAJ-Y0154, Olympus CV-190HET · Traditional | Olympus Medical Systems Corp. | 03/01/2013SE |
| K111425 | Olympus LTF-S190-10, Olumpus OTV-S190, Olympus CLV-S190HET · Traditional | Olympus Medical Systems Corp. | 04/20/2012SE |
| K111788 | Endoeye HD IIHET · Traditional | Olympus America, Inc. | 01/13/2012SE |
| K101458 | Lina Xcise Model MOR-1515HET · Traditional | Lina Medical Aps | 03/11/2011SE |
| K091010 | Trokamed MorcellatorHET · Traditional | Trokamed GmbH | 03/01/2011SE |
| K100280 | Gyncare Morcellex Tissue MorcellatorHET · Traditional | ETHICON, Inc. | 03/24/2010SE |
| K080365 | Morce Power Plus and Variocarve MorcellatorHET · Traditional | Nouvag AG | 06/29/2009SE |
| K081173 | Endoscopic CO2 Regulation Unit UcrHET · Traditional | Olympus Medical Systems Corporation | 12/23/2008SE |
| K082451 | Stryker VideoscopeHET · Traditional | Stryker Endoscopy | 12/16/2008SE |
| K080948 | HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VHHET · Traditional | Olympus Medical Systems Corporation | 09/26/2008SE |
| K062097 | Veress Cannula and Modular Veress CannulaHET · Traditional | PAJUNK GmbH Medizintechnologie | 10/13/2006SE |
| K062169 | Applied Laparoscopic Disposable Monopolar ScissorsHET · Traditional | Applied Medical Resources Corp. | 08/24/2006SE |
| K061268 | G-Lix Tissue GrasperHET · Traditional | Usgi Medical | 07/31/2006SE |
| K061050 | Gynecare Morcellex Tissue Morcellator, Models MX0100 and MX0100RHET · Traditional | ETHICON, Inc. | 07/14/2006SE |
| K050404 | Intuitive Surgical Da Vinci Surgical System and Endoscopic InstrumentsHET · Traditional | Intuitive Surgical, Inc. | 04/21/2005SE |
| K043013 | Miltex Laparoscopic InstrumentsHET · Traditional | Miltex, Inc. | 03/04/2005SE |
| K041321 | Veroscope Optical Veress Cannula & Dilation Tube SystemHET · Traditional | Richard Wolf Medical Instruments Corp. | 07/09/2004SE |
| K040295 | Applied Laparoscopic Monopolar ScissorsHET · Traditional | Applied Medical Resources Corp. | 03/12/2004SE |
| K033177 | Powergrip Bipolar Coagulation Forceps, Model 824XXXXXHET · Special | Gunter Bissinger Medizintechnik GmbH | 03/11/2004SE |
| K021237 | Coopersurgical Laparoscopic InstrumentsHET · Traditional | CooperSurgical, Inc. | 04/10/2003SE |
| K022384 | Xenon Fiberoptic Light Source, Model 1300 XSBPHET · Traditional | Isolux America | 10/18/2002SE |
| K022748 | Reprocssed Used Disposable Endoscopic Scissors and GraspersHET · Traditional | Medical Device Services | 10/09/2002SE |
| K020143 | Vasoview 5 Harvesting CannulaHET · Traditional | Guidant Corporation, Cardiac Surgery | 02/20/2002SE |
| K003805 | Gynecological LaparoscopesHET · Traditional | Global Endoscopy, Inc. | 07/22/2001SE |
| K010510 | Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1HET · Traditional | A & A Medical, Inc. | 05/16/2001SE |
| K003417 | Mini Fiber Endoscopes; Outer Sheaths; Veress Cannulas; Veress Cannulas with Outer…HET · Special | Richard Wolf Medical Instruments Corp. | 04/04/2001SE |
| K003164 | Trocars Trotec with Automatic Protective MechanismHET · Traditional | Richard Wolf Medical Instruments Corp. | 01/08/2001SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | Xomed, Inc. | 06/09/2000SE |
| K001220 | Endopath Sureseal Reducer CapHET · Traditional | Ethicon Endo-Surgery, Inc. | 05/16/2000SE |
| K000199 | Cortek Mini LaparoscopeHET · Traditional | Cortek Endoscopy, Inc. | 04/13/2000SE |
| K992513 | Therme-Pneu Computer, Wisap #7070C, #7070CF, #7070CM, #7070CMFHET · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 03/17/2000SE |
| K992481 | CO2-OP-PNEU Computer, Wisap #7050C, #7050CF, #7050CMFHET · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 03/17/2000SE |
| K993801 | Gynecare Laparoscopic MorcellatorHET · Traditional | ETHICON, Inc. | 02/07/2000SE |
| K990372 | Modular Instrument System for Minimal Invasive SurgeryHET · Traditional | Dr. Fritz GmbH | 10/14/1999SE |
| K992480 | Medifix Single and Double Puncture LaparoscopesHET · Traditional | Medifix, Inc. | 09/23/1999SE |
| K990732 | Lap-Wave 3000 (P07)HET · Traditional | W.O.M. World of Medicine GmbH | 07/23/1999SE |
| K990004 | Dci EndoscopeHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/02/1999SE |
| K982276 | Baho Autoclavable LaparoscopeHET · Traditional | Microptix Int'L, LLC | 02/18/1999SE |
| K982515 | Power-Drive, Wisap Model #7688PD/7688PD1HET · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 01/19/1999SE |
| K982518 | Aqua Purator-Biotherm, Wisap Model # 1608HET · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 01/14/1999SE |
| K982428 | Christoudias Gauze Dissector (Laparoscopic Hand Instrument)HET · Traditional | Innervision, Inc. | 10/09/1998SE |
| K982149 | Smith & Nephew Dyonics MicrolaparoscopeHET · Traditional | Smith & Nephew, Inc. | 09/10/1998SE |
| K981130 | Ksea Endo Tip SystemHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/19/1998SE |
| K970712 | Laparo-TenserHET · Traditional | L & T S.N.C. DI E. Lucini & C. | 07/21/1998SE |
| K974763 | Deroyal Industries Disposable Surgical Trocar/CannulaHET · Traditional | Deroyal Industries, Inc. | 07/10/1998SE |
| K970968 | Bissinger Detachable Bipolar Coagulation-ForcepsHET · Traditional | Guenter Bissinger Medizintechnik GmbH | 05/21/1998SE |
| K980694 | Ksea Plastic TrocarsHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/08/1998SE |
| K972647 | CO2 Pneumo-DissectorHET · Traditional | Cook Urological, Inc. | 04/10/1998SE |
| K980166 | Lightsource or IlluminatorHET · Traditional | Cuda Products Co. | 04/01/1998SE |
| K972488 | Ksea Hydromat 263110-20 Pressure Chambers and AccessoriesHET · Traditional | Karl Storz Endoscopy | 01/22/1998SE |
| K962985 | Ksea C.C.L. Vaginal Extractor and AccessoriesHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/19/1997SE |
| K973737 | Mini Trocar Sleeve and Trocars 3.5 MM, Micro Trocar Sleeve and Trocars 2 MM, Dilatation…HET · Traditional | Richard Wolf Medical Instruments Corp. | 12/12/1997SE |
| K973304 | MVM 3.3 MM MicroendoscopeHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/02/1997SE |
| K971836 | Verrescope, Light Cable - Light Source AdaptorHET · Traditional | CooperSurgical, Inc. | 11/07/1997SE |
| K971896 | Galileo High Resolution Micro CouplerHET · Traditional | Netoptix Corp. | 10/10/1997SE |
| K971837 | Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820HET · Traditional | CooperSurgical, Inc. | 08/06/1997SE |
| K962777 | Amr Mini-LaparoscopeHET · Traditional | Applied Medical Resources | 08/06/1997SE |
| K971797 | Laparoscopic Bladder Neck Suspension KitHET · Traditional | Louisville Laboratories, Inc. | 07/22/1997SE |
| K965045 | Tristar LP Torcar with Low Profile Threaded SleeveHET · Traditional | Ethicon Endo-Surgery, Inc. | 05/05/1997SE |
| K971255 | Imagyn Expandable Laparoscopic IntroducerHET · Traditional | Imagyn Medical, Inc. | 04/21/1997SE |
| K963076 | Laparoscopic Bone Anchored Urethropexy Instrument TrayHET · Traditional | Louisville Laboratories, Inc. | 04/04/1997SE |
| K965121 | CannulaHET · Traditional | Origin Medsystems, Inc. | 03/20/1997SE |
| K970151 | Interceptre Laparoscopic InstrumentsHET · Traditional | Smith & Nephew, Inc. | 03/18/1997SE |
| K965055 | Imagyn Microlap and Micro Lap-Gold LaparoscopesHET · Traditional | Imagyn Medical, Inc. | 03/06/1997SE |
| K970105 | Riwo Cut-Morcellator Existing of Knife/Cutting Sleeve/Protection Sleeve/Claw Grasping…HET · Traditional | Richard Wolf Medical Instruments Corp. | 03/04/1997SE |
| K960640 | S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)HET · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 02/14/1997SE |
| K962246 | Rigid Fiber Optic LaparoscopeHET · Traditional | Health Care International Assoc. | 02/07/1997SE |
| K964436 | Western Surgical Reusable Laparoscopic Trocar SystemHET · Traditional | Western Surgical Instrument Co. | 01/30/1997SE |
| K964379 | Ksea Puncture CannulaHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/29/1997SE |
| K963872 | Femrx Morcellator SystemHET · Traditional | Gynecare Innovation Center | 01/17/1997SE |
| K964450 | Secondary Trocar and Sleeve with Insufflation PortHET · Traditional | Pilling Weck Group | 01/10/1997SE |
| K963960 | Ksea Unimat PlusHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/20/1996SE |
| K963949 | Ksea Unimat PlusHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/19/1996SE |
| K960299 | Pyramid Trocar, 10MM W/Spring Ret. Protective Sleeve or Trocar W/Spring Loaded…HET · Traditional | Richard Wolf Medical Instruments Corp. | 10/28/1996SE |
| K960810 | Balloon Cannula 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X…HET · Traditional | Marlo Surgical Technology | 10/21/1996SE |
| K962090 | Karl Storz Model 203210 O1 Unimat PlusHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/30/1996SE |
| K963359 | Insufflation NeedleHET · Traditional | Applied Medical Resources | 09/24/1996SE |
| K961860 | A4907 Lens Cleaning SheathHET · Traditional | Olympus America, Inc. | 08/29/1996SE |
| K961922 | RDP-2HET · Traditional | Ranfac, Corp. | 08/09/1996SE |
| K960936 | Resposable Trocar System [5MM, 5MM Short, 10MM and 12MM Sizes]HET · Traditional | Origin Medsystems, Inc. | 07/24/1996SE |
| K960347 | Safety Trocer with Springloaded ObduratorHET · Traditional | Spiess Design, Inc. | 07/01/1996SE |
| K954774 | Shielded Trocar (Obturator)HET · Traditional | Gabris Surgical Corp. | 06/07/1996SE |
| K950335 | Karl Storz Rigid Telescopes for Obsterics and GynecologyHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/16/1996SE |
| K955412 | A.S.D. Safety TrocarHET · Traditional | American Surgical Devices | 05/14/1996SE |
| K954775 | Flo-Stat Fluid Monitoring SystemHET · Traditional | Gynecare Innovation Center | 05/10/1996SE |
| K960262 | Coring MorcellatorHET · Traditional | Cook Urological, Inc. | 04/15/1996SE |
| K951343 | Karl Storz Semi-Rigid Micro-Endoscopes & Accessories for Endosccopic Gynecological…HET · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/11/1996SE |
| K955403 | Oes Laparo-Thoraco Videoscope Type VHET · Traditional | Olympus America, Inc. | 03/11/1996SE |
| K955456 | Oes Laparo-Thoraco Videoscope (Rigid)HET · Traditional | Olympus America, Inc. | 02/22/1996SE |
| K942389 | Trocars, Trocar Sleeves and Reduction SleevesHET · Traditional | Hogan & Hartson | 02/16/1996SE |
| K953360 | R-Med Abdominal Wall ElevatorHET · Traditional | R-Med, Inc. | 01/11/1996SE |
| K952889 | INSUL-COAT/2 Ceramic Coated Endo Medical InstrumentsHET · Traditional | Materials Conversion Corp. | 12/22/1995SE |
| K953364 | SpeculiteHET · Traditional | Trylon Corp. | 12/08/1995SE |
| K943305 | Olympus 3D Surgical Endoscopy SystemHET · Traditional | Olympus America, Inc. | 11/17/1995SE |
| K953809 | Karl Storz Take-Apart Biopolar ForcepsHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/06/1995SE |
| K942838 | Olympus Superview Laparoscope for OB/GYNHET · Traditional | Olympus America, Inc. | 10/31/1995SE |
| K951105 | Karl Storz Pressure Cuff for Use with the Ksea Hydromat PumpHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/20/1995SE |
| K954520 | Microsurge Veress NeedleHET · Traditional | Microsurge, Inc. | 10/16/1995SE |
| K942431 | Laporoscopic ScissorsHET · Traditional | Enterprise Medical Corp. | 10/11/1995SE |
| K953190 | Ksea Model 203200 20 UnimatHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/05/1995SE |
| K953574 | Nezhat-Dorsey Hydro-Dissection Universal Bag SqueezerHET · Traditional | American Hydro-Surgical Instruments, Inc. | 09/29/1995SE |
| K940265 | Patton Laparoscopic Catheter Introducer SetHET · Traditional | Cook Urological, Inc. | 09/28/1995SE |
| K953548 | Laparoscopic Surgical InstrumentHET · Traditional | Gabris Surgical Corp. | 09/19/1995SE |
| K944200 | Hi-Q Hand Instruments, OB/GYN UseHET · Traditional | Olympus America, Inc. | 09/15/1995SE |
| K951250 | Karl Storz Suction CathetersHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/07/1995SE |
| K952508 | Flow-Therme, Wisap #7642HET · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 08/25/1995SE |
| K943100 | Stryker Operating LaparoscopeHET · Traditional | Stryker Endoscopy | 08/10/1995SE |
| K944270 | Cit Monopolar Laparoscopic InstrmentsHET · Traditional | Chirurgische Instrumente | 07/25/1995SE |
| K941206 | Dual Valve Aspiration/Lavage Cannula and Aspiration/Suction ProbeHET · Traditional | New Eder Corp. | 07/25/1995SE |
| K951394 | Karl Storz Pediatric Vancaillie, Manhes Take-Apart Bipolar Forceps, Bipolar Coagulation…HET · Traditional | KARL STORZ Endoscopy-America, Inc. | 07/20/1995SE |
| K950962 | Karl Storz Hok Needle Holders, Forceps for Suturing, Suture Scissors, Tissue Probes…HET · Traditional | KARL STORZ Endoscopy-America, Inc. | 07/12/1995SE |
| K946380 | Nezhat-Dorsey Reusable Aspiration-Vac Probes with and Without Puncture Cannula…HET · Traditional | American Hydro-Surgical Instruments, Inc. | 07/06/1995SE |
| K943713 | Torcars,Cannulae,Sheaths,ObturatorsHET · Traditional | Karl Storz Endoskop GmbH | 06/30/1995SE |
| K951190 | Karl Storz Puncture, Injection, Endoscopic, Veress NeedleHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/14/1995SE |
| K951490 | LasevacHET · Traditional | D.D. Surgical, Inc. | 06/13/1995SE |
| K946147 | Kse Steiner Electromechanic MorcellatorHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/25/1995SE |
| K943662 | LaparascopeHET · Traditional | Pollux Endoscopy, Inc. | 05/25/1995SE |
| K950108 | R-Med Mini-RetractorHET · Traditional | R-Med, Inc. | 05/11/1995SE |
| K946359 | Karl Storz Dilation Set, Reducers, Thread Sleeves, Distance HoldersHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/11/1995SE |
| K950457 | Cannual and Trocar, SuperpubicHET · Traditional | Core Dynamics, Inc. | 05/05/1995SE |
| K945685 | Karl Storz Telescope Bridges and Inserts, AdaptersHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/05/1995SE |
| K942730 | Aesculap LaparoscopesHET · Traditional | Aesculap, Inc. | 04/25/1995SE |
| K942411 | R-Med Disposable PlugHET · Traditional | R-Med, Inc. | 03/31/1995SE |
| K945211 | Karl Storz Retractore, Probes, Dissectors, Hooks, Uterineelevators, Uterine CannulaeHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/30/1995SE |
| K943603 | Aesculap Laparoscopic Ancillary DevicesHET · Traditional | Aesculap, Inc. | 03/29/1995SE |
| K945982 | Karl Storz Take-Apart(R) Suture Forceps, Knot TierHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/21/1995SE |
| K943053 | Ksea Semm Tissur PunchHET · Traditional | Karl Storz Endoskop GmbH | 03/21/1995SE |
| K932779 | Birtcher Swivel Grip Laparoscopic Probes & Access.HET · Traditional | Birtcher Medical Systems, Inc. | 03/21/1995SE |
| K950232 | Laparoscope and Accessories for OB/GYNHET · Traditional | Olympus America, Inc. | 03/16/1995SE |
| K941507 | Themo-Flo System 3 Laparoscopic/Hysteroscopic SystemHET · Traditional | Sanese Medical Corp. | 03/06/1995SE |
| K932387 | Conceptus Vari-Soft Cath/Pirouette Posit MandrelHET · Traditional | Conceptus, Inc. | 03/06/1995SE |
| K945741 | Trocar and Cannula AccessoryHET · Traditional | Applied Medical Resources | 02/28/1995SE |
| K932276 | CO2 Hydromat Pump for Irrigation, Model #26310020HET · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/28/1995SE |
| K942973 | Hasson Stabilizing Access Cannula (Sac)HET · Traditional | Entec Corp. | 02/27/1995SE |
| K946235 | Conmed 7/8MM Gasket Reducer for Use with Trogard(Tm) Trocar SleeveHET · Traditional | Conmedcorp | 02/13/1995SE |
| K944268 | Cit Two Way Suctin and Irrigation TubesHET · Traditional | Chirurgische Instrumente | 01/26/1995SE |
| K943810 | Imagyn Microlap IntroducerHET · Traditional | Imagyn Medical, Inc. | 01/26/1995SE |
| K945100 | Karl Storz Suction/Irrigation Tubes, CannulaeHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/24/1995SE |
| K944269 | Cit Grasping and Dissecting ForcepsHET · Traditional | Chirurgische Instrumente | 01/24/1995SE |
| K944079 | Imagyn Microlap(Tm) LaparoscopeHET · Traditional | Imagyn Medical, Inc. | 01/20/1995SE |
| K936273 | Stereo Opsis Camera System 3-D Distal Cam and 3-D Distal Cam 360HET · Traditional | Baxter Healthcare Corp | 01/06/1995SE |
| K944555 | EndoscopeHET · Traditional | United States Surgical, A Division of Tyco Healthc | 12/30/1994SE |
| K944563 | Family of Primus Forceps: Graspers/Dissectors/Suturers/Needle DriversHET · Traditional | Marlow Surgical Technologies, Inc. | 12/27/1994SE |
| K934799 | Conmed TrogardHET · Traditional | Conmedcorp | 12/21/1994SE |
| K942447 | Hasson Open Laparoscopy CannulaHET · Traditional | Linvatec Corp. | 12/15/1994SE |
| K931065 | LaparoviewHET · Traditional | Northgate Technologies, Inc. | 11/30/1994SE |
| K943508 | Insufflator Tubing with FilterHET · Traditional | Stryker Endoscopy | 11/17/1994SE |
| K944245 | Dynabite Laparoscopic ForcepsHET · Traditional | Portlyn Corp. | 11/15/1994SE |
| K944129 | Imagyn Laparoscopic InstrumentsHET · Traditional | Imagyn Medical, Inc. | 10/20/1994SE |
| K943598 | Flexible Fiber Optic LaparoscopesHET · Traditional | Optimed Technologies, Inc. | 10/18/1994SE |
| K931478 | Zeiss Opmi L Stereo-LaparoscopeHET · Traditional | Carl Zeiss, Inc. | 09/28/1994SE |
| K936011 | Invamed Reusable Laparoscopic Trocar SystemHET · Traditional | Invamed, Inc. | 09/21/1994SE |
| K926259 | SurgimatHET · Traditional | W.O.M. World of Medicine GmbH | 09/14/1994SE |
| K925079 | Laparoscopic Inst. (Scissors,Forceps,Needleholder)HET · Traditional | Endo Technic Corp. | 08/24/1994SE |
| K936071 | Smith & Nephew Dyonics Inc. Electronic EndoscopeHET · Traditional | Smith & Nephew Dyonics, Inc. | 08/19/1994SE |
| K941944 | Tahoe Surgical Instruments Ligature DeviceHET · Traditional | Tahoe Surgical Instruments P.R., Inc. | 07/25/1994SE |
| K940718 | Innervision Inc. Laparoscopic Hand InstrumentsHET · Traditional | Innervision, Inc. | 07/22/1994SE |
| K921294 | Video Endoscope-Rigid ModificationHET · Traditional | Medical Dynamics, Inc. | 07/20/1994SE |
| K926597 | Laparoscope, Gynecologic (and Accessories)HET · Traditional | Optimed Technologies, Inc. | 07/12/1994SE |
| K924611 | Irrigation Pump and Tubing SetHET · Traditional | Marlo Surgical Technology | 06/30/1994SE |
| K933768 | Coagulator, Laparoscopic, Lunipolar/AccessoriesHET · Traditional | Mahe-Medizintechnik | 06/27/1994SE |
| K940505 | Articulating Laparoscopic Retracotor (Uresil)HET · Traditional | Uresil Corp. | 06/21/1994SE |
| K941208 | Diagnostic Sleeve, Reducer SleeveHET · Traditional | New Eder Corp. | 06/17/1994SE |
| K941334 | Davol Laparoscopic Suction Irrigation ProbeHET · Traditional | Davol, Inc. | 06/14/1994SE |
| K926596 | Owens Endoscopic Instruments and AccessoriesHET · Traditional | Owens Industries, Inc. | 06/10/1994SE |
| K923260 | Laparoscopy Sets, Needle Holders, Blunt CurvedHET · Traditional | Imtec Corp. | 06/09/1994SE |
| K926594 | Owens Laparoscopy Instruments and AccessoriesHET · Traditional | Owens Industries, Inc. | 06/06/1994SE |
| K940709 | Scissors, Grasping Forceps, Needle Holders, DissectorsHET · Traditional | Baxter Healthcare Corp | 05/19/1994SE |
| K935785 | Karl Storz Irrigation and Suction System Handpiece and AccessoriesHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/11/1994SE |
| K941094 | Insufflation Tubing & FilterHET · Traditional | H & C Chemical, Inc. | 05/10/1994SE |
| K940462 | Hydromat Trumpet Valve and Tubing Set for Laparoscopic Suction and IrrigationHET · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/10/1994SE |
| K940049 | Knot Pusher, Spoon Forceps and Biopsy ForcepsHET · Traditional | Baxter Healthcare Corp | 05/06/1994SE |
| K940844 | Myoma Drill 5MM-8383.611HET · Traditional | Richard Wolf Medical Instruments Corp. | 05/02/1994SE |
| K921722 | Bard(R) Leventhal(Tm) Gyne-Flo(Tm) CannulaHET · Traditional | Bard Reproductive Systems | 05/02/1994SE |
| K925968 | EndoscopeHET · Traditional | United States Surgical, A Division of Tyco Healthc | 04/28/1994SE |
| K935031 | Riza-Ribe NeedleHET · Traditional | R-Med, Inc. | 04/25/1994SE |
| K931771 | Birtcher Endoscopic CorkscrewHET · Traditional | Birtcher Medical Systems, Inc. | 04/25/1994SE |
| K931654 | Birtcher Magnetic Retriever (GS-3100)HET · Traditional | Birtcher Medical Systems, Inc. | 04/25/1994SE |
| K941494 | Endo-Assist Laparoscopic InstrumentsHET · Traditional | Sharpe Endosurgical Corp. | 04/22/1994SE |
| K932689 | Lapro-Loader(Tm)HET · Traditional | Surgimark, Inc. | 04/11/1994SE |
| K923259 | Laparoscopy Sets, Needle Holders, Blunt ShearsHET · Traditional | Imtec Corp. | 04/11/1994SE |
| K926021 | Needle Holders & Access for Lapar Surg-Ob/Gyn UseHET · Traditional | Zinnanti Surgical Instruments, Inc. | 04/07/1994SE |
| K933492 | Esys SystemHET · Traditional | Endolap, Inc. | 03/25/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1473-2024 Class II | Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CEInadequate reprocessing validation evidence | Karl Storz Endoscopy | 02/27/2024Open, Classified |
| Z-0645-2024 Class II | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used…Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the… | Olympus Corporation of the Americas | 11/20/2023Open, Classified |
| Z-0644-2024 Class II | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used…Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the… | Olympus Corporation of the Americas | 11/20/2023Open, Classified |
| Z-0697-2024 Class II | Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a…Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device… | Olympus Corporation of the Americas | 11/06/2023Open, Classified |
| Z-0573-2024 Class II | Injection Needle, LUER-lock,0.8mm, REF: 26175PDThe efficacy of the manual cleaning process cannot be assured for the affected injection needles intended… | Karl Storz Endoscopy | 10/24/2023Open, Classified |
| Z-0833-2022 Class II | (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5…The finished device package did not contain the IFU. | Carefusion 2200 Inc | 02/23/2022Terminated |
| Z-1929-2017 Class II | Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg.…A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become… | Olympus Corporation of the Americas | 02/10/2017Terminated |
| Z-0403-2016 Class II | Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree…A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive… | Olympus Corporation of the Americas | 11/17/2015Terminated |
| Z-2145-2014 Class II | Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic…Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use… | Market-Tiers Inc | 07/16/2014Terminated |
| Z-0173-2010 | Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health &…There is the potential for the duckbill seal to become dislodged. | Ethicon, Inc. | 09/28/2009Terminated |
| Z-0026-2009 | Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | Applied Medical Resources Corp | 06/25/2008Terminated |
| Z-0025-2009 | Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | Applied Medical Resources Corp | 06/25/2008Terminated |
| Z-0024-2009 | Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | Applied Medical Resources Corp | 06/25/2008Terminated |
| Z-0023-2009 | Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | Applied Medical Resources Corp | 06/25/2008Terminated |