The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Karl Storz Flexible Hd Cysto-urethroscope System.
| Device ID | K212476 |
| 510k Number | K212476 |
| Device Name: | KARL STORZ Flexible HD Cysto-Urethroscope System |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Thomas Ostrowski KARL STORZ Endoscopy America, Inc. 2151 E. Grand Ave El 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 | 2021-08-06 |
| Decision Date | 2021-09-03 |