The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Karl Storz Insulated Dissecting Cannulae, Cannulae, Suction Tubes, Insert Tubes.
| Device ID | K944823 |
| 510k Number | K944823 |
| Device Name: | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1994-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551365304 | K944823 | 000 |
| 04048551266090 | K944823 | 000 |
| 04048551266083 | K944823 | 000 |
| 04048551260234 | K944823 | 000 |
| 04048551260227 | K944823 | 000 |
| 04048551159453 | K944823 | 000 |
| 04048551159309 | K944823 | 000 |
| 04048551155646 | K944823 | 000 |
| 04048551155523 | K944823 | 000 |
| 04048551121344 | K944823 | 000 |
| 04048551089989 | K944823 | 000 |
| 04048551089958 | K944823 | 000 |
| 04048551088609 | K944823 | 000 |
| 04048551097878 | K944823 | 000 |
| 04048438003510 | K944823 | 000 |
| 04048551310786 | K944823 | 000 |
| 04048551310779 | K944823 | 000 |
| 04048551258125 | K944823 | 000 |
| 04048551155790 | K944823 | 000 |
| 04048551155707 | K944823 | 000 |
| 04048551155561 | K944823 | 000 |
| 04048551107669 | K944823 | 000 |
| 04048551098967 | K944823 | 000 |
| 04048551097816 | K944823 | 000 |
| 04048551097656 | K944823 | 000 |
| 04048551095591 | K944823 | 000 |
| 04048551095577 | K944823 | 000 |
| 04048551088531 | K944823 | 000 |