510(k) K101333 ยท GEH Unit, Cryosurgical, Accessories
CRYOCARE CS SURGICAL SYSTEM
| Applicant | Endocare, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jun 14, 2010 |
| Received | May 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101333
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2013 | Healthtronics, Inc. HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue. Terminated |
GEH | None listed |
| Mar 21, 2012 | Healthtronics, Inc. CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes.
Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissu Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.