The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Flexible Sensor-ureterorenoscopes Boa Vision Ef, Flexible Sensor-ureterorenoscopes Cobra Vision Ef.
| Device ID | K183188 |
| 510k Number | K183188 |
| Device Name: | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Contact | Mike Loiterman |
| Correspondent | Mike 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 | 2018-11-19 |
| Decision Date | 2019-05-03 |