The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Endoscopic Needle Driver.
| Device ID | K960011 |
| 510k Number | K960011 |
| Device Name: | ENDOSCOPIC NEEDLE DRIVER |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Victor Clavelli |
| Correspondent | Victor Clavelli UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-02-21 |