The following data is part of a premarket notification filed by Urologix, Inc. with the FDA for Prostiva Rf Therapy Generator, Prostiva Rf Therapy Hand Piece, Prostiva Rf Therapy Return Electrode, Prostiva Rf Therapy Tubing System, Prostiva Rf Therapy Telescope.
| Device ID | K142248 |
| 510k 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 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Urologix, Inc. 14405 21st Avenue North Minneapolis, MN 55447 |
| Contact | Georgiann Keyport |
| Correspondent | Georgiann Keyport Urologix, Inc. 14405 21st Avenue North Minneapolis, MN 55447 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-14 |
| Decision Date | 2015-02-20 |
| Summary: | summary |