The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc with the FDA for Flexible Video Cysto-urethroscope (c-view).
| Device ID | K202957 |
| 510k Number | K202957 |
| Device Name: | Flexible Video Cysto-Urethroscope (C-view) |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ Endoscopy-America, Inc 2151 E. Grand Avenue Ei Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ Endoscopy-America, Inc 2151 E. Grand Avenue Ei Segundo, CA 90245 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2020-10-29 |