The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Biop/bask Cut/grasp Dissec/flex/cut Forc.
| Device ID | K934937 |
| 510k Number | K934937 |
| Device Name: | KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1994-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551098479 | K934937 | 000 |
| 04048551094679 | K934937 | 000 |
| 04048551094570 | K934937 | 000 |
| 04048551094518 | K934937 | 000 |
| 04048551094495 | K934937 | 000 |
| 04048551094341 | K934937 | 000 |
| 04048551094266 | K934937 | 000 |
| 04048551094242 | K934937 | 000 |
| 04048551343289 | K934937 | 000 |
| 04048551343272 | K934937 | 000 |
| 04048551094846 | K934937 | 000 |
| 04048551094860 | K934937 | 000 |
| 04048551097243 | K934937 | 000 |
| 04048551098370 | K934937 | 000 |
| 04048551086780 | K934937 | 000 |
| 04048551052013 | K934937 | 000 |
| 04048551050217 | K934937 | 000 |
| 04048551048283 | K934937 | 000 |
| 04048551048276 | K934937 | 000 |
| 04048551111789 | K934937 | 000 |
| 04048551111734 | K934937 | 000 |
| 04048551097410 | K934937 | 000 |
| 04048551230855 | K934937 | 000 |