The following data is part of a premarket notification filed by Covidien, Formerly Us Surgical A Divison Of Tyco H with the FDA for Versaport V2 Bladeless Optical Trocar.
| Device ID | K130435 |
| 510k Number | K130435 |
| Device Name: | VERSAPORT V2 BLADELESS OPTICAL TROCAR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Contact | Sarah Rizk |
| Correspondent | Sarah Rizk COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2013-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521657714 | K130435 | 000 |
| 20884521657677 | K130435 | 000 |
| 20884521657660 | K130435 | 000 |
| 20884521181400 | K130435 | 000 |
| 20884521181394 | K130435 | 000 |
| 20884521181387 | K130435 | 000 |
| 20884521181370 | K130435 | 000 |
| 20884521181363 | K130435 | 000 |
| 20884521717692 | K130435 | 000 |
| 20884521657691 | K130435 | 000 |
| 20884521657707 | K130435 | 000 |
| 20884521181325 | K130435 | 000 |
| 20884521657684 | K130435 | 000 |
| 20884521545141 | K130435 | 000 |
| 20884521215402 | K130435 | 000 |
| 20884521215396 | K130435 | 000 |
| 20884521215389 | K130435 | 000 |
| 20884521181356 | K130435 | 000 |
| 20884521181349 | K130435 | 000 |
| 20884521181332 | K130435 | 000 |
| 20884521717685 | K130435 | 000 |