Gyrus Acmi, Inc.
Medical device manufacturer in Westborough, MA.
43510(k) clearances
2PMA approvals
33recalls
Device types
- GEI Electrosurgical, Cutting & Coagulation &… 20
- ERL Drill, Surgical, Ent (Electric Or… 3
- KCT Sterilization Wrap Containers, Trays… 3
- HIN Coagulator-Cutter, Endoscopic, Bipolar (And… 2
- GEX Powered Laser Surgical Instrument 2
- FAS Electrode, Electrosurgical, Active… 2
- KNS Unit, Electrosurgical, Endoscopic (With Or… 1
- HIG Insufflator, Hysteroscopic 1
- FGA Kit, Nephroscope 1
- HIH Hysteroscope (And Accessories) 1
- LJE Catheter, Nephrostomy 1
- EOB Nasopharyngoscope (Flexible Or Rigid) 1
- HHI System, Abortion, Vacuum 1
- FGE Stents, Drains And Dilators For The Biliary… 1
- LYA Splint, Intranasal Septal 1
- FAJ Cystoscope And Accessories, Flexible/Rigid 1
- FGB Ureteroscope And Accessories, Flexible/Rigid 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)GEI · Traditional | 03/02/2026SE |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…FGB · Traditional | 03/25/2024SE |
| K231327 | POWERSEAL Sealer and DividerGEI · Traditional | 10/25/2023SE |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…GEX · Traditional | 01/27/2023SE |
| K212650 | Celeris, Disposable Sinus DebriderERL · Traditional | 01/19/2022SE |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGEI · Special | 01/04/2022SE |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…GEX · Special | 06/03/2021SE |
| K181696 | ChitoZolveLYA · Traditional | 11/30/2018SE |
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation CatheterFGE · Traditional | 03/08/2018SE |
| K171440 | Berkeley VC-10 Vacuum Curettage SystemHHI · Special | 09/29/2017SE |
| K170908 | PK AimGEI · Traditional | 05/19/2017SE |
| K163373 | PK AimGEI · Special | 12/12/2016SE |
| K161038 | PK MorcellatorGEI · Traditional | 10/07/2016SE |
| K161825 | PK AimGEI · Traditional | 09/26/2016SE |
| K152744 | Diego Elite DrillERL · Traditional | 06/10/2016SE |
| K152531 | InstaClear Lens CleanerEOB · Traditional | 01/15/2016SE |
| K152219 | PK AimGEI · Traditional | 12/17/2015SE |
| K142759 | PK Cutting Forceps for ESG-400 WorkstationGEI · Traditional | 01/13/2015SE |
| K142350 | PK J-HookGEI · Traditional | 01/08/2015SE |
| K142289 | PK SpatulaGEI · Traditional | 12/31/2014SE |
| K142154 | PK NeedleGEI · Traditional | 12/19/2014SE |
| K132383 | Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation CatheterLJE · Traditional | 02/04/2014SE |
| K123429 | Olympus Energy Power System (Eps)GEI · Traditional | 04/05/2013SE |
| K122605 | PKS BillHIN · Special | 12/05/2012SE |
| K121678 | DtadERL · Traditional | 08/30/2012SE |
| K120474 | Gyrus Acmi Telescope Storage-Sterilization TrayKCT · Traditional | 07/10/2012SE |
| K120567 | Gyrus Amci PK Button ElectrodeFAS · Traditional | 06/20/2012SE |
| K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)HIN · Traditional | 09/01/2011SE |
| K110852 | Dolphin 3 Fluid Management SystemHIG · Traditional | 07/19/2011SE |
| K102970 | Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTKCT · Traditional | 05/20/2011SE |
| K092571 | Gyrus Acmi Biocoag ProbeKNS · Traditional | 10/20/2010SE |
| K100816 | PK Superpulse Sysem Generator Model 744000GEI · Traditional | 07/01/2010SE |
| K100896 | Gyrus Acmi Halo PKS Cutting ForcepsGEI · Special | 06/17/2010SE |
| K093181 | Gyrus Acmi PK Button ElectrodeFAS · Traditional | 02/24/2010SE |
| K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysKCT · Traditional | 12/11/2009SE |
| K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model IDH-4HIH · Traditional | 09/29/2009SE |
| K080844 | G3 Generator and Accessories-Dissector Plasma KnifeGEI · Traditional | 08/13/2009SE |
| K090814 | Modification to Gyrus Acmi Invisio Icn, Models ICN-0564 and ICN-0565FAJ · Special | 04/20/2009SE |
| K083013 | PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…GEI · Traditional | 12/09/2008SE |
| K082054 | Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch…GEI · Special | 08/06/2008SE |
| K081954 | Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGEI · Special | 07/31/2008SE |
| K080093 | PKS Plasma Morcellator, Models 962000PK, 3620PKGEI · Traditional | 05/02/2008SE |
| K072594 | Gyrus Acmi IPN-2505, Invisio Smith Percutaneous Nephroscope SystemFGA · Traditional | 12/13/2007SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1187-2019 Class II | Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1186-2019 Class II | Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1185-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XCOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1184-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1183-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SCOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1182-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1181-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SCOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1180-2019 Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SSOlympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1179-2019 Class II | Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No…Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1178-2019 Class II | Olympus Diego Elite Console MDCONS 100Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with… | 03/08/2019Terminated |
| Z-1952-2018 Class II | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A…There is a potential for the cord to spark and cause a fire. | 04/17/2018Terminated |
| Z-1337-2018 Class II | Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system"Chattering" when cutting burrs are used in bone. | 08/03/2017Open, Classified |
| Z-1753-2015 Class II | Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding…Potential lack of sterility assurance. | 05/08/2015Terminated |
| Z-1752-2015 Class II | Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding…Potential lack of sterility assurance. | 05/08/2015Terminated |
| Z-0419-2015 Class II | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF…All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging… | 10/21/2014Terminated |
| Z-1439-2013 Class II | GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only…lack of sterility assurance | 05/24/2013Terminated |
| Z-0411-2013 Class II | PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO…One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene… | 10/17/2012Terminated |
| Z-2383-2011 | Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile…Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their… | 04/15/2011Terminated |
| Z-2651-2010 | GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344…Lack of sterility assurance due to compromised package seals. | 08/06/2010Terminated |
| Z-2436-2010 | The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while…Gyrus Medical, Inc. has issued a Urgent Medical Device Recall for the Gyrus ACMI product 004942-903 -… | 08/03/2010Terminated |
| Z-0797-2010 | MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO…Units of the product in lot MH136952 may have been shipped without being sterilized. | 01/08/2010Terminated |
| Z-0637-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0636-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0635-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0634-2010 | Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device is…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0633-2010 | Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0632-2010 | Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is…Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK -… | 08/18/2009Terminated |
| Z-0273-2009 | Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only…Sterility may be compromised | 10/01/2008Terminated |
| Z-2226-2008 | Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608…Particulate matter in the catheter | 06/25/2008Terminated |
| Z-1073-2007 | Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System…Sterilization Instructions not adequate for sterilizing. | 05/23/2007Terminated |
| Z-0615-2007 | Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number:…Product sterility may be compromised due to failure of the tray seal packaging | 02/19/2007Terminated |
| Z-0614-2007 | Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901Product sterility may be compromised due to failure of the tray seal packaging | 02/19/2007Terminated |
| Z-0613-2007 | Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32Product sterility may be compromised due to failure of the tray seal packaging | 02/19/2007Terminated |