# Gyrus Medical, Inc.

- Location (FDA's records): Maple Grove, MN
- FDA decisions: 23 (1990–2005): 23 510(k) clearances
- Names in FDA's records: Gyrus Medical, Inc. (15); Gyrus Medical , Ltd. (8)
- Product codes: GEI (16), KNS (3), HIH (2), FJL (1), JRE (1)
- Predicates its devices cite: 34 (10 its own); citations of its devices by later devices: 44 (10 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Everest Medical Corp.: 11 (https://510kreport.com/company/everest-medical)
- Comeg Endoscopy: 2 (https://510kreport.com/company/comeg-endoscopy)
- Gyrus Ent LLC: 2 (https://510kreport.com/company/gyrus-ent)
- Gynecare, Inc.: 2 (https://510kreport.com/company/gynecare)
- Valleylab, Inc.: 2 (https://510kreport.com/company/valleylab)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- Erbe USA, Inc.: 1 (https://510kreport.com/company/erbe-usa)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)

## Firms that cite its devices most
- Gyrus Acmi, Inc.: 18 (https://510kreport.com/company/gyrus-acmi)
- Olympus Winter & Ibe GmbH: 2 (https://510kreport.com/company/olympus-winter-ibe)
- Live Tissue Connect, Inc.: 2 (https://510kreport.com/company/live-tissue-connect)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)
- Acmi Corporation: 1 (https://510kreport.com/company/acmi)
- National Advanced Endoscopy Devices, Inc.: 1 (https://510kreport.com/company/national-advanced-endoscopy-devices)
- Plasma Surgical, Ltd.: 1 (https://510kreport.com/company/plasma-surgical)
- Livsmed, Inc.: 1 (https://510kreport.com/company/livsmed)

## Its most-cited devices
- K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories) (2003), cited by 7
- K050550: Gyrus General Purpose Electrosurgical Generator (2005), cited by 5
- K990628: Gyrus Endourology System (1999), cited by 4
- K024286: Gyrus Open Forceps (2003), cited by 4
- K041285: Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes) (2004), cited by 3
- K031079: Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode (2003), cited by 3

## Recent decisions
- K050550: Gyrus General Purpose Electrosurgical Generator (Nov 9, 2005)
- K050460: Gyrus Plasmacision and Plasmablend Electrodes (Oct 25, 2005)
- K041999: Gyrus Plasma Skin Resurfacing System (Mar 2, 2005)
- K041633: Gyrus Plasmacision Laparoscopic Spatula (Oct 22, 2004)
- K041285: Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes) (Sep 10, 2004)
- K024286: Gyrus Open Forceps (Nov 17, 2003)
- K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories) (Jul 21, 2003)
- K031081: Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors (May 21, 2003)

Source page: https://510kreport.com/company/gyrus-medical