The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Trocar Cannula.
| Device ID | K963115 |
| 510k Number | K963115 |
| Device Name: | TROCAR CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson 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 | 1996-08-12 |
| Decision Date | 1997-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521094505 | K963115 | 000 |
| 10884521078468 | K963115 | 000 |
| 10884521078451 | K963115 | 000 |
| 10884521078444 | K963115 | 000 |
| 10884521078437 | K963115 | 000 |
| 10884521078390 | K963115 | 000 |
| 10884521078376 | K963115 | 000 |
| 10884521134553 | K963115 | 000 |
| 20884521080789 | K963115 | 000 |
| 20884521080772 | K963115 | 000 |
| 10884521078512 | K963115 | 000 |
| 10884521094178 | K963115 | 000 |
| 10884521094109 | K963115 | 000 |
| 10884521078413 | K963115 | 000 |
| 10884521078406 | K963115 | 000 |
| 10884521078475 | K963115 | 000 |
| 10884521078536 | K963115 | 000 |
| 10884521094475 | K963115 | 000 |
| 10884521094451 | K963115 | 000 |
| 10884521093591 | K963115 | 000 |
| 10884521093584 | K963115 | 000 |
| 10884521082595 | K963115 | 000 |
| 10884521082588 | K963115 | 000 |
| 10884521081352 | K963115 | 000 |
| 10884521081345 | K963115 | 000 |
| 10884521078529 | K963115 | 000 |
| 10884521078420 | K963115 | 000 |
| 20884521180625 | K963115 | 000 |
| 10884521078543 | K963115 | 000 |
| 10884521078383 | K963115 | 000 |
| 20884521180618 | K963115 | 000 |
| 10884521078482 | K963115 | 000 |