The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Continuous Irrigation Cystourethroscope.
| Device ID | K935163 |
| 510k Number | K935163 |
| Device Name: | CONTINUOUS IRRIGATION CYSTOURETHROSCOPE |
| Classification | Cystourethroscope |
| 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 | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-29 |
| Decision Date | 1994-09-07 |