The following data is part of a premarket notification filed by Karl Storz Endoscopy America with the FDA for Flexible Video-uretero-renoscope Ssu System.
| Device ID | K212458 |
| 510k Number | K212458 |
| Device Name: | Flexible Video-Uretero-Renoscope SSU System |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ Endoscopy America 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Mario Trujillo |
| Correspondent | Mario Trujillo KARL STORZ Endoscopy America 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-05 |
| Decision Date | 2022-01-20 |