Data / Medical devices / United States / Gyrus ACMI, Inc.
Gyrus ACMI, Inc.: FDA-registered device maker in Brooklyn Park, MN, United States, 221 510(k) clearances and 1 PMA approval
Gyrus ACMI, Inc. is registered with the FDA (registration 3011050570) in Brooklyn Park, MN, United States. It lists 151 device types. The FDA files 221 510(k) clearances and 1 PMA approval under its listings, the newest dated March 2, 2026. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011050570
- Address
- 9600 Louisiana Ave North, Brooklyn Park, MN, United States, 55445
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- January 20, 1995
- Registered through
- 2027
- Brand names listed
- 006902-902, 188, 2-3/4 Needle Electrode, 20714 (HYSTEROSCOPE), 21G EBUS Needle, 568618, 70140095, 70890728 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 221.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 2, 2026 | K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| October 7, 2025 | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | GEI | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| August 23, 2024 | K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| October 25, 2023 | K231327 | POWERSEAL Sealer and Divider | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| January 19, 2023 | K221522 | HF-cables (resusable) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| March 9, 2022 | K220069 | 4K UHD LCD Monitor OEV321UH | GCJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 19, 2022 | K212650 | Celeris, Disposable Sinus Debrider | ERL | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| January 4, 2022 | K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| September 27, 2021 | K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action | GEI | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| August 4, 2021 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | LFL | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| April 28, 2021 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| February 19, 2021 | K202346 | SPiN Vision Video Bronchoscope System | EOQ | Substantially Equivalent | Veran Medical Technologies, Inc. | accessdata.fda.gov |
| March 18, 2020 | K193517 | ViziShot 2 FLEX | KTI | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| April 4, 2019 | K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | ODC | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| November 30, 2018 | K181696 | ChitoZolve | LYA | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| July 3, 2018 | K181193 | PeriView FLEX | KTI | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| March 29, 2018 | K172298 | OLYMPUS URF-P6/P6R | FGB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 8, 2018 | K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter | FGE | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| February 15, 2018 | K173877 | BOWA Neutral Electrodes | GEI | Substantially Equivalent | Bowa-Electronics GmbH & Co. KG | accessdata.fda.gov |
| September 29, 2017 | K171440 | Berkeley VC-10 Vacuum Curettage System | HHI | Substantially Equivalent | Gyrus Acmi | accessdata.fda.gov |
| August 21, 2017 | K171024 | ShockPulse-SE Lithotripsy System | FEO | Substantially Equivalent | Cybersonics, Inc. | accessdata.fda.gov |
| May 15, 2017 | K170023 | SPiN Thoracic Navigation System | JAK | Substantially Equivalent | Veran Medical Technologies, Inc. | accessdata.fda.gov |
| April 6, 2017 | K163469 | ViziShot 2 FLEX | KTI | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| December 9, 2016 | K162205 | Arc EndoCuff and Arc EndoCuff Vision | FED | Substantially Equivalent | Boddingtons Plastics, Ltd. | accessdata.fda.gov |
| November 22, 2016 | K153773 | Disposal Lens Cleaning Sheath | GCJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| June 10, 2016 | K152744 | DIEGO ELITE DRILL | ERL | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| May 6, 2016 | K160053 | Monopolar single-use HF cable | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| March 22, 2016 | K160098 | Single Use Aspiration Needle NA-U401SX | FCG | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 15, 2016 | K152531 | InstaClear Lens Cleaner | EOB | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| February 20, 2015 | K150024 | Bissinger Monopolar Cables | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| February 8, 2015 | K142680 | ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT | NEZ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 8, 2015 | K142350 | PK J-HOOK | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| December 31, 2014 | K142289 | PK Spatula | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| December 19, 2014 | K142154 | PK NEEDLE | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| November 21, 2014 | K142525 | PK Lap Loop | HIN | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 13, 2014 | K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | FEO | Substantially Equivalent | Cybersonics, Inc. | accessdata.fda.gov |
| May 19, 2014 | K132703 | THUNDERBEAT | GEI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| February 4, 2014 | K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER | LJE | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| October 21, 2013 | K132181 | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER | EZN | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| October 11, 2013 | K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| April 22, 2013 | K122167 | NEXXIS OR | DXJ | Substantially Equivalent | Barco N.V. | accessdata.fda.gov |
| April 5, 2013 | K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| February 4, 2013 | K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH | KNY | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| December 14, 2012 | K123319 | GYRUS ACMI BICOAG HEMOSTASIS PROBE | KNS | Substantially Equivalent | Olympus Surgical Technologies America | accessdata.fda.gov |
| December 5, 2012 | K122605 | PKS BILL | HIN | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| August 30, 2012 | K121678 | DTAD | ERL | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| July 20, 2012 | K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | HQP | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| June 29, 2012 | K121701 | SYSTEMS INTEGRATION | GCJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| June 5, 2012 | K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | FFK | Substantially Equivalent | Cybersonics, Inc. | accessdata.fda.gov |
| February 15, 2011 | K102763 | SYSTEMS INTEGRATION | ODA | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| January 5, 2011 | K102379 | LTF-Y0009; MAJ-YOO41; XOEV-3D1 | GCJ | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 17, 2010 | K100896 | GYRUS ACMI HALO PKS CUTTING FORCEPS | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| March 10, 2010 | K093507 | OLYMPUS CHF TYPE Y0003 | FBN | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| February 24, 2010 | K093181 | GYRUS ACMI PK BUTTON ELECTRODE | FAS | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| December 9, 2008 | K083013 | PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| November 5, 2008 | K082720 | TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 | EOQ | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| September 26, 2008 | K080948 | HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH | HET | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| August 8, 2008 | K081766 | PKS OMNI INSTRUMENT | GEI | Substantially Equivalent | Gyrus-Acmi L.P. | accessdata.fda.gov |
| July 31, 2008 | K081954 | GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| May 2, 2008 | K080093 | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| December 14, 2007 | K072552 | MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| June 23, 2006 | K060243 | OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 | EOQ | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| November 9, 2005 | K050550 | GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| October 25, 2005 | K050460 | GYRUS PLASMACISION AND PLASMABLEND ELECTRODES | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| September 2, 2005 | K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | KNY | Substantially Equivalent | Acmi Corporation | accessdata.fda.gov |
| August 16, 2005 | K052044 | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL | FGB | Substantially Equivalent | Acmi Corporation | accessdata.fda.gov |
| March 3, 2005 | K043581 | DUAL LUMEN CATHETER | EYB | Substantially Equivalent | Acmi Corporation | accessdata.fda.gov |
| December 9, 2004 | K043275 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER | IYO | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| November 8, 2004 | K042516 | OTOMIMIX | NEA | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| October 22, 2004 | K041633 | GYRUS PLASMACISION LAPAROSCOPIC SPATULA | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| September 10, 2004 | K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | GEI | Substantially Equivalent | Gyrus Medical , Ltd. | accessdata.fda.gov |
| August 2, 2004 | K033222 | OLYMPUS STERILIZATION TRAYS | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| March 3, 2004 | K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | ERL | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| March 3, 2004 | K032840 | ATRION MEDICAL QL INFLATION DEVICE | KOE | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| November 17, 2003 | K024286 | GYRUS OPEN FORCEPS | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| November 14, 2003 | K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B | FGE | Substantially Equivalent | Aomori Olympus Co., Ltd. | accessdata.fda.gov |
| October 16, 2003 | K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | EOQ | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| July 21, 2003 | K031085 | GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| July 16, 2003 | K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | FCL | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| June 3, 2003 | K030684 | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH | OCU | Substantially Equivalent | Acmi Corporation | accessdata.fda.gov |
| May 21, 2003 | K031082 | EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| May 21, 2003 | K031079 | EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| May 16, 2003 | K031080 | EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| May 16, 2003 | K031078 | EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| May 2, 2003 | K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE | HAW | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| February 11, 2003 | K021852 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES | GEI | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| January 31, 2003 | K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES | EOQ | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| November 29, 2002 | K023767 | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES | GEI | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| November 13, 2002 | K023492 | EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| August 30, 2002 | K022543 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM | FAS | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| August 22, 2002 | K022480 | ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC | HIH | Substantially Equivalent | Acmi Corporation | accessdata.fda.gov |
| August 2, 2002 | K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | KCT | Substantially Equivalent | Symmetry Medical, Inc. | accessdata.fda.gov |
| May 28, 2002 | K020778 | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 | GEI | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| May 9, 2002 | K021166 | ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR | FDC | Substantially Equivalent | Acmi-Circon Corporation | accessdata.fda.gov |
| April 9, 2002 | K012758 | URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, | FGB | Substantially Equivalent | Circon Video | accessdata.fda.gov |
| April 4, 2002 | K020067 | GYRUS ENT SOMNOPLASTY GENERATOR | GEI | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| March 8, 2002 | K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | ERL | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| January 8, 2002 | K011876 | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | HIG | Substantially Equivalent | Circon Video | accessdata.fda.gov |
| December 10, 2001 | K011849 | MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS | FGB | Substantially Equivalent | Circon Video | accessdata.fda.gov |
| November 19, 2001 | K012929 | FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 | FAJ | Substantially Equivalent | Circon Video | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 29, 1993 | P870076 | FALOPE RING BAND AND APPLICATOR SYSTEMS | KNH | 26 | May 19, 2021 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 27, 2014 | 69226 | Class II | Terminated | GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG | Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. | accessdata.fda.gov |
| July 8, 2014 | 68768 | Class II | Terminated | Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring | Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator. | accessdata.fda.gov |
| February 19, 2014 | 67578 | Class II | Terminated | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dua | Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen. | accessdata.fda.gov |
| July 24, 2013 | 65785 | Class II | Terminated | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use el | On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products | accessdata.fda.gov |
| May 15, 2006 | 35477 | Not yet classified | Terminated | GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic wit | Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists. | accessdata.fda.gov |
| December 5, 2003 | 27883 | Not yet classified | Terminated | Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. | The generator may malfunction when used in close proximity to a monopolar generator. | accessdata.fda.gov |
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Updated March 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.