The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Sensor-ureterorenoscope 9 Fr Wl 600 Mm (short Riwo D-urs), Adapter For Controller 5525.
| Device ID | K201897 |
| 510k Number | K201897 |
| Device Name: | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Contact | Michael Loiterman |
| Correspondent | Michael Loiterman Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Product Code | FGB |
| Subsequent Product Code | FGA |
| Subsequent Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-08 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04055207064719 | K201897 | 000 |
| 04055207064184 | K201897 | 000 |