The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Conductive Surgigrip Spiral Sleeve.
| Device ID | K915338 |
| 510k Number | K915338 |
| Device Name: | CONDUCTIVE SURGIGRIP SPIRAL SLEEVE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-09-28 |