Company ยท US
Cosman Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2010. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 2010 | K101131 | FIDUCIAL MARKERS Cosman Medical, Inc. | IYE |
| Oct 16, 2008 | K082051 | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 Cosman Medical, Inc. | GXD |
| Oct 14, 2008 | K082012 | COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN Cosman Medical, Inc. | GXI |
| May 2, 2006 | K060799 | COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA Cosman Medical, Inc. | GXI |
| Apr 25, 2006 | K053415 | LESIONPOINT RF CANNULA Cosman Medical, Inc. | GXI |
| Mar 17, 2005 | K050084 | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; Cosman Medical, Inc. | GXI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2017 | Cosman Medical, LLC Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) Terminated |
GXI | K050084 |