Cosman Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cosman Medical, Inc.” (first 2005, latest 2010), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | 4 | 4 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
Review panels
Most recent Cosman Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101131 | FIDUCIAL MARKERS | IYE | 2010-06-17 | 56 |
| K082051 | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | GXD | 2008-10-16 | 90 |
| K082012 | COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN | GXI | 2008-10-14 | 91 |
| K060799 | COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA | GXI | 2006-05-02 | 39 |
| K053415 | LESIONPOINT RF CANNULA | GXI | 2006-04-25 | 139 |
| K050084 | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; | GXI | 2005-03-17 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Cosman Medical, 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 Cosman Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Cosman Medical, Inc.” (first 2005, latest 2010), across 3 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 Cosman Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cosman Medical, Inc. is 76 days.
Which FDA product codes appear under Cosman Medical, Inc.?
The most frequent FDA product codes under this applicant name are GXI (Probe, Radiofrequency Lesion, 4); GXD (Generator, Lesion, Radiofrequency, 1); IYE (Accelerator, Linear, Medical, 1).
Next steps
- See all 6 Cosman Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXI, Cosman 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.