# K982717: Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200

- Pathway: 510(k) (Traditional)
- Applicant: Somnus Medical Technologies, Inc.
- Decided: Nov 2, 1998 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
121 later devices descend from it; 3 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Somnus Model S2 Electrosurgical Generator: named in the summary without a submission number
- (no number) Somnus Tissue Coagulating Electrode Models 1000, 1010, 1200, 2000, 2010, 3000, 30XX, 6000: named in the summary without a submission number

## Most influential descendants
- K014290: Entec Plasma Wands (2002), 119 descendants of its own
- K021364: Modification to Entec Plasma Wands (2002), 94 descendants of its own
- K030108: Arthrocare Ent Coblator Surgery System (2003), 92 descendants of its own
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) (2002), 76 descendants of its own
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own

## Indications for use
The Somnoplasty™ System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS (Upper Airway Resistance Syndrome) or OSAS (Obstructive Sleep Apnea Syndrome).

Source page: https://510kreport.com/device/K982717
Methodology: https://510kreport.com/methodology