510(k) K060279 ยท GEH Unit, Cryosurgical, Accessories
CRYOCARE CS SURGICAL SYSTEM
| Applicant | Endocare, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Feb 28, 2006 |
| Received | Feb 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060279
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2010 | Endocare, Division Of Healthtronics Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip). Terminated |
GEH | None listed |
| 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.