Somnus Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Somnus Medical Technologies, Inc.” (first 1996, latest 2000), across 1 product code in 1 review panel. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 16 | 16 |
Review panels
Most recent Somnus Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000720 | SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE | GEI | 2000-05-30 | 88 |
| K001438 | SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR | GEI | 2000-05-16 | 8 |
| K000501 | ELECTROSURGICAL GENERATOR, MODEL S1 | GEI | 2000-03-17 | 31 |
| K982717 | SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 | GEI | 1998-11-02 | 90 |
| K973701 | SOMNUS TISSUE COAGULATING ELECTRODE | GEI | 1998-01-30 | 123 |
| K970838 | SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE | GEI | 1998-01-09 | 308 |
| K970837 | SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE | GEI | 1998-01-09 | 308 |
| K973618 | SOMNOPLASTY SYSTEM | GEI | 1997-12-19 | 87 |
| K971450 | SOMNOPLASTY SYSTEM | GEI | 1997-07-17 | 87 |
| K971711 | SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR | GEI | 1997-06-24 | 47 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Somnus Medical Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Somnus Medical Technologies, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Somnus Medical Technologies, Inc.” (first 1996, latest 2000), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Somnus Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Somnus Medical Technologies, Inc. is 87 days.
Which FDA product codes appear under Somnus Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 16).
Next steps
- See all 16 Somnus Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Somnus Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.