The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Wound Closure Instruments.
| Device ID | K942612 |
| 510k Number | K942612 |
| Device Name: | KARL STORZ WOUND CLOSURE INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson 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 | 1994-06-02 |
| Decision Date | 1994-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551407301 | K942612 | 000 |
| 04048551099292 | K942612 | 000 |
| 04048551099438 | K942612 | 000 |
| 04048551099452 | K942612 | 000 |
| 04048551160794 | K942612 | 000 |
| 04048551168165 | K942612 | 000 |
| 04048551168172 | K942612 | 000 |
| 04048551168189 | K942612 | 000 |
| 04048551323786 | K942612 | 000 |
| 04048551404713 | K942612 | 000 |
| 04048551404737 | K942612 | 000 |
| 04048551404829 | K942612 | 000 |
| 04048551404843 | K942612 | 000 |
| 04048551365311 | K942612 | 000 |
| 04048551097755 | K942612 | 000 |
| 04048551007266 | K942612 | 000 |