The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Neoscope - Endoscopic Diagnostic & Treatment System.
| Device ID | K042780 |
| 510k Number | K042780 |
| Device Name: | NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| 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 | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2005-02-03 |