510(k) K011074 ยท GEH Unit, Cryosurgical, Accessories
CRYOCARE SURGICAL SYSTEM
| Applicant | Endocare, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 25, 2002 |
| Received | Apr 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2010 | Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. V-Probe, Endocare Cryo V Probe model # Cryo 206V.
The product is used in a minimally invasive, percutaneous approach
to treating prostate cancer in low, moderate and high risk patients. Prostate Cryo Terminated |
GEH | None listed |
| Apr 16, 2010 | Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. V-Probe, Endocare Cryo V Probe, single unit model # CVA2400.
The product is used in a minimally invasive, percutaneous approach
to treating prostate cancer in low, moderate and high risk patients. Pro Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.