The following data is part of a premarket notification filed by Fiber Imaging Technologies, Inc. with the FDA for Uretero-renoscope.
| Device ID | K992527 |
| 510k Number | K992527 |
| Device Name: | URETERO-RENOSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Contact | Joseph Ress |
| Correspondent | Joseph Ress FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-28 |
| Decision Date | 1999-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851925007236 | K992527 | 000 |
| 00851925007250 | K992527 | 000 |
| 00851925007243 | K992527 | 000 |
| 00851925007212 | K992527 | 000 |
| 00851925007205 | K992527 | 000 |