The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Uretero-renoscope/ureterscope.
| Device ID | K940464 |
| 510k Number | K940464 |
| Device Name: | KARL STORZ URETERO-RENOSCOPE/URETERSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1994-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551347317 | K940464 | 000 |
| 04048551231333 | K940464 | 000 |
| 04048551232071 | K940464 | 000 |
| 04048551405307 | K940464 | 000 |
| 04048551405314 | K940464 | 000 |
| 04048551405451 | K940464 | 000 |
| 04048551405468 | K940464 | 000 |
| 04048551347249 | K940464 | 000 |
| 04048551347263 | K940464 | 000 |
| 04048551347287 | K940464 | 000 |
| 04048551426692 | K940464 | 000 |
| 04048551205044 | K940464 | 000 |