The following data is part of a premarket notification filed by Steris Corporation with the FDA for Uretero1 Ureteroscope System.
| Device ID | K211347 |
| 510k Number | K211347 |
| Device Name: | Uretero1 Ureteroscope System |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | STERIS Corporation 5976 Heisley Road Mentor, OH 44060 |
| Contact | Caroll Martin |
| Correspondent | Caroll Martin STERIS Corporation 5976 Heisley Road Mentor, OH 44060 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2021-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995209186 | K211347 | 000 |
| 10724995209176 | K211347 | 000 |
| 10724995209169 | K211347 | 000 |