# K970576: Somnus Model 615 Electrosurgical Generator (Model 615)

- Pathway: 510(k) (Traditional)
- Applicant: Somnus Medical Technologies, Inc.
- Decided: Apr 9, 1997 after 55 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.
No later device cites it as a predicate yet.
0 of 1 device 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: named in the summary without a submission number
- (no number) VidaMed Model 50: named in the summary without a submission number
- (no number) Vidamed Model 7205: named in the summary without a submission number
- (no number) Erbe ICC 50: named in the summary without a submission number

## Indications for use
The Somnus™ Model 615 Electrosurgical Generator and Accessories are intended for use with the Somnus Soft Tissue Coagulating Electrodes for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K970576
Methodology: https://510kreport.com/methodology