SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)— 510(k) K970576
Substantially EquivalentSomnus Medical Technologies, Inc.
FDA 510(k) clearance K970576 for SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615), Substantially Equivalent on 1997-04-09. Applicant: Somnus Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Somnus Medical Technologies, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code GEI
view allMore clearances from Somnus Medical Technologies, Inc.
view all- K000720 — SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE
- K001438 — SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
- K000501 — ELECTROSURGICAL GENERATOR, MODEL S1
- K982717 — SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200
- K973701 — SOMNUS TISSUE COAGULATING ELECTRODE
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.