The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Uretero-renoscope, Model 8706.402, Insertion Sheath, Model 8706.042.
| Device ID | K990050 |
| 510k Number | K990050 |
| Device Name: | URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Robert L Casarsa |
| Correspondent | Robert L Casarsa RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-07 |
| Decision Date | 1999-03-26 |
| Summary: | summary |