The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Flexible Hd Cysto-urethroscope System.
| Device ID | K191357 |
| 510k Number | K191357 |
| Device Name: | Flexible HD Cysto-Urethroscope System |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Irina Fedorov |
| Correspondent | Irina Fedorov KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-21 |
| Decision Date | 2019-09-18 |
| Summary: | summary |