# K971450: Somnoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Somnus Medical Technologies, Inc.
- Decided: Jul 17, 1997 after 87 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.
86 later devices descend from it; 3 cite it directly.
0 of 87 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 215 Electrosurgical Generator: named in the summary without a submission number
- (no number) Somnus Tissue Coagulating Electrode Models 1000, 2000: named in the summary without a submission number

## Most influential descendants
- 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
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own

## Indications for use
The Somnoplasty System is intended for coagulation (thermal ablation, tissue volume reduction) of soft tissue, including the uvula/soft palate and may reduce the severity of snoring in some individuals.

Source page: https://510kreport.com/device/K971450
Methodology: https://510kreport.com/methodology