The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Endoscopic Diagnostic & Treatment System (modification).
| Device ID | K120766 |
| 510k Number | K120766 |
| Device Name: | ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | PROSURG, INC. 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | A. Desai |
| Correspondent | A. Desai PROSURG, INC. 2195 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 | 2012-03-13 |
| Decision Date | 2012-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851545007623 | K120766 | 000 |
| 10851545007590 | K120766 | 000 |
| 10851545007606 | K120766 | 000 |
| 10851545007613 | K120766 | 000 |
| 10851545007637 | K120766 | 000 |
| 10851545007644 | K120766 | 000 |
| 10851545007651 | K120766 | 000 |
| 10851545007668 | K120766 | 000 |
| 10851545007675 | K120766 | 000 |
| 10851545007682 | K120766 | 000 |
| 10851545007699 | K120766 | 000 |
| 10851545007736 | K120766 | 000 |
| 00851545007500 | K120766 | 000 |
| 00851545007548 | K120766 | 000 |
| 00851545007531 | K120766 | 000 |
| 00851545007463 | K120766 | 000 |
| 00851545007470 | K120766 | 000 |
| 00851545007487 | K120766 | 000 |
| 10851545007583 | K120766 | 000 |