SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)— 510(k) K963772
Substantially EquivalentSomnus Medical Technologies, Inc.
FDA 510(k) clearance K963772 for SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225), Substantially Equivalent on 1996-10-23. Applicant: Somnus Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Somnus Medical Technologies, Inc.
- Product code
- Product 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
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- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
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- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
More 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.