# Gyrus Ent LLC

- Location (FDA's records): Bartlett, TN
- FDA decisions: 28 (1997–2004): 28 510(k) clearances
- Product codes: ETB (7), GEI (5), ERL (4), ETA (3), ETD (2), HAW (1), NIX (1), EQJ (1), EOB (1), ETN (1), KKX (1), KHJ (1)
- Predicates its devices cite: 25 (7 its own); citations of its devices by later devices: 34 (7 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrocare Corp.: 6 (https://510kreport.com/company/arthrocare)
- Somnus Medical Technologies, Inc.: 5 (https://510kreport.com/company/somnus-medical-technologies)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Smith & Nephew Richards, Inc.: 2 (https://510kreport.com/company/smith-nephew-richards)
- Everest Medical Corp.: 1 (https://510kreport.com/company/everest-medical)
- Ellman Intl., Inc.: 1 (https://510kreport.com/company/ellman-intl)

## Firms that cite its devices most
- Grace Medical, Inc.: 8 (https://510kreport.com/company/grace-medical)
- Gyrus Acmi, Inc.: 6 (https://510kreport.com/company/gyrus-acmi)
- Gyrus Medical, Inc.: 2 (https://510kreport.com/company/gyrus-medical)
- Hemostatix Medical Technologies, LLC: 2 (https://510kreport.com/company/hemostatix-medical-technologies)
- Medline Renewal: 1 (https://510kreport.com/company/medline-renewal)
- Bien-Air Surgery SA: 1 (https://510kreport.com/company/bien-air-surgery)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Heinz Kurz: 1 (https://510kreport.com/company/heinz-kurz)

## Its most-cited devices
- K034004: Diego RF Powered Dissector and Drill System Console (2004), cited by 6
- K020594: Diego Powered Dissector and Drill System (2002), cited by 5
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) (2002), cited by 3
- K003214: Smith & Nephew Pistons (2000), cited by 3
- K002021: Hemostatix Thermal Scalpel System - #12 Blade (2000), cited by 2
- K030343: Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface (2003), cited by 2

## Recent decisions
- K040996: Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System (Aug 20, 2004)
- K034004: Diego RF Powered Dissector and Drill System Console (Mar 3, 2004)
- K033089: Hemostatix, Model 2400Z Thermal Scalpel System (Feb 5, 2004)
- K033554: Smart Offset Stapes Piston; Smart Isj Prosthesis (Nov 24, 2003)
- K030343: Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface (May 2, 2003)
- K021595: Gyrus Ent Nerve Stimulator (Oct 24, 2002)
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) (Aug 26, 2002)
- K020778: Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420 (May 28, 2002)

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