510(k) K102360 ยท GEH Unit, Cryosurgical, Accessories
ICESENCE 3
| Applicant | IceCure Medical , Ltd., Caesaria, IL |
| Decision | Substantially Equivalent, Nov 29, 2010 |
| Received | Aug 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102360
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2023 | Icecure Medical Ltd IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures
Models:
(1)FAS3000000 (100-127 VAC);
(2) Open, Classified |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.