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 Endoscopic Fascia Stapler.
| Device ID | K912097 |
| 510k Number | K912097 |
| Device Name: | AUTO SUTURE ENDOSCOPIC FASCIA STAPLER |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521070605 | K912097 | 000 |
| 20884521070599 | K912097 | 000 |
| 20884521070575 | K912097 | 000 |
| 20884521070568 | K912097 | 000 |
| 20884521070551 | K912097 | 000 |
| 20884521070544 | K912097 | 000 |
| 20884521070537 | K912097 | 000 |
| 20884521070520 | K912097 | 000 |