510(k) K113380 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 15, 2012 |
| Received | Nov 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2013 | Urologix, Inc. Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide.
The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. P Terminated |
GEI | None listed |
| Apr 2, 2013 | Medtronic Neuromodulation Medtronic Prostiva RF Therapy Generator.
The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men ov Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.