PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
FDA 510(k) clearance K113380 · decided 2012-11-15
Clearance details
- K-number
- K113380
- Device name
- PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-16
- Decision date
- 2012-11-15
- Days to decision
- 365 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. Th recall (Z-0182-2014) | Urologix, Inc. | 2013-11-08 |
| Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treat recall (Z-1031-2013) | Medtronic Neuromodulation | 2013-04-02 |
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