Vidamed, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Vidamed, Inc.” (first 1995, latest 2002), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 79 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 | 7 | 7 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 4 | 4 |
Review panels
Most recent Vidamed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014224 | PRECISION PLUS TUNA OFFICE SYSTEM | GEI | 2002-01-23 | 28 |
| K012587 | RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE | KNS | 2001-12-11 | 123 |
| K011787 | PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE | KNS | 2001-07-06 | 28 |
| K002583 | TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM | KNS | 2001-02-13 | 179 |
| K973366 | COBRA HAND PIECE | KNS | 1997-11-26 | 79 |
| K965199 | TUNA 5 CATHETER | GEI | 1997-04-30 | 125 |
| K965061 | VIDAMED MODEDL 7600 RF GENERATOR | GEI | 1997-01-28 | 41 |
| K963180 | VIDAMED RF GENERATOR DATA RECORDER | GEI | 1996-10-10 | 57 |
| K960918 | VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM | GEI | 1996-10-08 | 216 |
| K955035 | VIDAMED SERIES 7205 ELECTROSURGICAL GENERATOR | GEI | 1995-11-29 | 27 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vidamed, 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 Vidamed, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Vidamed, Inc.” (first 1995, latest 2002), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vidamed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vidamed, Inc. is 79 days.
Which FDA product codes appear under Vidamed, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 4).
Next steps
- See all 11 Vidamed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Vidamed, 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.