# Somnus Medical Technologies, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 16 (1996–2000): 16 510(k) clearances
- Product codes: GEI (16)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 17 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Gyrus Ent LLC: 5 (https://510kreport.com/company/gyrus-ent)
- Celon AG Medical Instruments: 2 (https://510kreport.com/company/celon-ag-medical-instruments)
- Medsphere International, Inc.: 1 (https://510kreport.com/company/medsphere-international)
- Restore Medical, Inc.: 1 (https://510kreport.com/company/restore-medical)
- Vnus Medical Technologies, Inc.: 1 (https://510kreport.com/company/vnus-medical-technologies)
- AtriCure, Inc.: 1 (https://510kreport.com/company/atricure)
- Pi Medical: 1 (https://510kreport.com/company/pi-medical)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)

## Its most-cited devices
- K982717: Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 (1998), cited by 3
- K971450: Somnoplasty System (1997), cited by 3
- K973618: Somnoplasty System (1997), cited by 3
- K000501: Electrosurgical Generator, Model S1 (2000), cited by 2
- K963884: Somnus Disposable Multiple Electrode Coagulating Probe Model 350 (1996), cited by 2
- K000720: Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector Cable (2000), cited by 1

## Recent decisions
- K000720: Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector Cable (May 30, 2000)
- K001438: Somnus Model S2 Electrosurgical Generator (May 16, 2000)
- K000501: Electrosurgical Generator, Model S1 (Mar 17, 2000)
- K982717: Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 (Nov 2, 1998)
- K973701: Somnus Tissue Coagulating Electrode (Jan 30, 1998)
- K970838: Somnus Model 30XX Disposable Tri-Needle Coagulating Electrode (Jan 9, 1998)
- K970837: Somnus Model 6000 Disposable Tissue Coagulating Electrode (Jan 9, 1998)
- K973618: Somnoplasty System (Dec 19, 1997)

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