510(k) K091721 ยท GEH Unit, Cryosurgical, Accessories
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
| Applicant | New Medical Technologies GmbH, Plymouth Meeting PA, US |
| Decision | Substantially Equivalent, Oct 2, 2009 |
| Received | Jun 11, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | New Medical Technologies Gmbh Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516; Open, Classified |
GEH | None listed |
| Feb 5, 2025 | New Medical Technologies Gmbh Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517; Open, Classified |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.