Sanarus Medical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Sanarus Medical, Inc.” (first 2002, latest 2008), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 7 | 7 |
| KNW | Instrument, Biopsy | 6 | 6 |
| FZP | Clip, Implantable | 1 | 1 |
Review panels
Most recent Sanarus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080171 | SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 | KNW | 2008-03-06 | 42 |
| K073533 | SANARUS V2 TREATMENT SYSTEM | GEH | 2008-02-07 | 52 |
| K062896 | V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 | GEH | 2007-01-03 | 98 |
| K061510 | SANARUS VISICA TREATMENT SYSTEM | GEH | 2006-07-18 | 47 |
| K052861 | MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 | GEH | 2005-11-15 | 35 |
| K051581 | SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 | KNW | 2005-07-27 | 42 |
| K042136 | SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM | KNW | 2004-09-08 | 30 |
| K032506 | SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM | KNW | 2003-10-09 | 56 |
| K020054 | SANARUS INDICA MARKER SYSTEM | FZP | 2002-10-16 | 281 |
| K022314 | SANARUS VISICA TREATMENT SYSTEM | GEH | 2002-10-15 | 90 |
4 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2003-06-16.
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 Sanarus Medical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Sanarus Medical, Inc.” (first 2002, latest 2008), across 3 product codes 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 Sanarus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sanarus Medical, Inc. is 50 days.
Which FDA product codes appear under Sanarus Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 7); KNW (Instrument, Biopsy, 6); FZP (Clip, Implantable, 1).
Next steps
- See all 14 Sanarus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Sanarus Medical, 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.