The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for The Karl Storz 11274 Series Flexible Fiberscope.
| Device ID | K925128 |
| 510k Number | K925128 |
| Device Name: | THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1993-08-18 |