The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Flexible Video-uretero-choledochoscope System.
| Device ID | K142556 |
| 510k Number | K142556 |
| Device Name: | Flexible Video-Uretero-Choledochoscope System |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo, CA 90245 |
| Contact | Mike Samuels |
| Correspondent | Mike Samuels KARL STORZ ENDOSCOPY-AMERICA, INC. 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 | 2014-09-11 |
| Decision Date | 2014-10-23 |
| Summary: | summary |