510(k) K023757 ยท GEH Unit, Cryosurgical, Accessories
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
| Applicant | Endocare, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Dec 5, 2002 |
| Received | Nov 8, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023757
| 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.