The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Autosuture Modified Versaport Trocar With Fixation Sleeve.
| Device ID | K062326 |
| 510k Number | K062326 |
| Device Name: | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Daniel Campion |
| Correspondent | Daniel Campion 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-09 |
| Decision Date | 2006-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521094437 | K062326 | 000 |
| 10884521081277 | K062326 | 000 |
| 10884521081291 | K062326 | 000 |
| 10884521081314 | K062326 | 000 |
| 10884521081338 | K062326 | 000 |
| 10884521082687 | K062326 | 000 |
| 10884521094116 | K062326 | 000 |
| 10884521094284 | K062326 | 000 |
| 10884521094406 | K062326 | 000 |
| 10884521081253 | K062326 | 000 |