The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Adult & Pediatric Nephroscope.
| Device ID | K940594 |
| 510k Number | K940594 |
| Device Name: | KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE |
| Classification | Kit, Nephroscope |
| 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 | FGA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-09 |
| Decision Date | 1994-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551366608 | K940594 | 000 |
| 04048551082485 | K940594 | 000 |
| 04048551082447 | K940594 | 000 |
| 04048551082409 | K940594 | 000 |
| 04048551082386 | K940594 | 000 |
| 04048551080429 | K940594 | 000 |
| 04048551080382 | K940594 | 000 |
| 04048551391907 | K940594 | 000 |
| 04048551366653 | K940594 | 000 |
| 04048551329986 | K940594 | 000 |
| 04048551082508 | K940594 | 000 |
| 04048551072806 | K940594 | 000 |
| 04048551072837 | K940594 | 000 |
| 04048551350324 | K940594 | 000 |
| 04048551348741 | K940594 | 000 |
| 04048551347584 | K940594 | 000 |
| 04048551426654 | K940594 | 000 |
| 04048551366660 | K940594 | 000 |
| 04048551072899 | K940594 | 000 |
| 04048551082836 | K940594 | 000 |
| 04048551072875 | K940594 | 000 |
| 04048551072851 | K940594 | 000 |
| 04048551233429 | K940594 | 000 |