The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Surgiwand.
| Device ID | K961771 |
| 510k Number | K961771 |
| Device Name: | AUTO SUTURE SURGIWAND |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-08 |
| Decision Date | 1996-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884523000983 | K961771 | 000 |
| 20884523000938 | K961771 | 000 |
| 20884523000921 | K961771 | 000 |
| 20884523000914 | K961771 | 000 |
| 20884523000907 | K961771 | 000 |
| 20884523000891 | K961771 | 000 |
| 20884523000884 | K961771 | 000 |
| 20884523000877 | K961771 | 000 |
| 20884523000860 | K961771 | 000 |