The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Autosuture Endoscopic Suturing Device.
| Device ID | K934738 |
| 510k Number | K934738 |
| Device Name: | AUTOSUTURE ENDOSCOPIC SUTURING DEVICE |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Paul D Smolenski |
| Correspondent | Paul D Smolenski 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 | 1993-10-01 |
| Decision Date | 1994-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521128972 | K934738 | 000 |
| 10884521126763 | K934738 | 000 |
| 10884521126756 | K934738 | 000 |
| 10884521126749 | K934738 | 000 |
| 10884521126732 | K934738 | 000 |
| 10884521126619 | K934738 | 000 |
| 10884521126602 | K934738 | 000 |
| 10884521126596 | K934738 | 000 |
| 10884521126589 | K934738 | 000 |
| 10884521126572 | K934738 | 000 |
| 20884521129440 | K934738 | 000 |
| 20884521129464 | K934738 | 000 |
| 20884521129457 | K934738 | 000 |
| 20884521129433 | K934738 | 000 |
| 20884521126890 | K934738 | 000 |
| 20884521100012 | K934738 | 000 |
| 10884521126770 | K934738 | 000 |
| 10884521126787 | K934738 | 000 |
| 10884521127012 | K934738 | 000 |
| 10884521127005 | K934738 | 000 |
| 10884521126992 | K934738 | 000 |
| 10884521126985 | K934738 | 000 |
| 10884521126978 | K934738 | 000 |
| 10884521126961 | K934738 | 000 |
| 10884521126954 | K934738 | 000 |
| 10884521126909 | K934738 | 000 |
| 10884521126855 | K934738 | 000 |
| 10884521126848 | K934738 | 000 |
| 10884521126831 | K934738 | 000 |
| 10884521126824 | K934738 | 000 |
| 10884521126817 | K934738 | 000 |
| 10884521126800 | K934738 | 000 |
| 10884521126794 | K934738 | 000 |
| 20884521100005 | K934738 | 000 |