Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope
FDA 510(k) clearance K142248 · decided 2015-02-20
Clearance details
- K-number
- K142248
- Device name
- Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope
- Applicant
- Urologix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-14
- Decision date
- 2015-02-20
- Days to decision
- 190 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
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| UROLOGIX PROSTATRON SYSTEM (P950014/S026) | Urologix, Inc. | 2008-07-16 |
| UROLOGIX PROSTATRON SYSTEM (P950014/S025) | Urologix, Inc. | 2005-05-25 |
| PROSTATRON (P950014/S024) | Urologix, Inc. | 2005-02-23 |
| PROSTATRON (P950014/S023) | Urologix, Inc. | 2005-02-18 |
| PROSTATRON PRAKTIS (P950014/S022) | Urologix, Inc. | 2004-06-10 |
| PROSTATRON (TM) SYSTEM DISPOSABLE TREATMENT APPLICATOR (P950014/S021) | Urologix, Inc. | 2001-09-19 |
| PROSTATRON (P950014/S020) | Urologix, Inc. | 2000-04-13 |
| PROSTATRON PRAKTIS (P950014/S019) | Urologix, Inc. | 1999-11-05 |