The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Insulated Dissecting Cannulae, Cannulae, Suction Tubes.
| Device ID | K944862 |
| 510k Number | K944862 |
| Device Name: | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 91 CARPENTER HILL RD. Charlton, MA 01507 -3578 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 91 CARPENTER HILL RD. Charlton, MA 01507 -3578 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1995-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551155806 | K944862 | 000 |
| 04048551155769 | K944862 | 000 |
| 04048551155752 | K944862 | 000 |
| 04048551155677 | K944862 | 000 |
| 04048551155578 | K944862 | 000 |
| 04048551155530 | K944862 | 000 |