The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Turbt-rf Electrodes And Electrosurgical Devices.
| Device ID | K050488 |
| 510k Number | K050488 |
| Device Name: | TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-25 |
| Decision Date | 2005-04-01 |