The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Flexible Cmos-video-cysto-urethroscope.
| Device ID | K131364 |
| 510k Number | K131364 |
| Device Name: | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE |
| Classification | Cystourethroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 -5017 |
| Contact | Shiven Gandhi |
| Correspondent | Shiven Gandhi KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 -5017 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2014-01-02 |
| Summary: | summary |