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 Optiical Trocar And/or Versaport Bladeless Optical Trocar.
| Device ID | K112349 |
| 510k Number | K112349 |
| Device Name: | VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT 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 | Angela V Arsdale |
| Correspondent | Angela V Arsdale 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 | 2011-08-16 |
| Decision Date | 2011-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40884521215437 | K112349 | 000 |
| 20884521134215 | K112349 | 000 |
| 20884521134222 | K112349 | 000 |
| 20884521134239 | K112349 | 000 |
| 20884521134246 | K112349 | 000 |
| 20884521134253 | K112349 | 000 |
| 20884521134260 | K112349 | 000 |
| 20884521657622 | K112349 | 000 |
| 20884521657639 | K112349 | 000 |
| 20884521657646 | K112349 | 000 |
| 20884521657653 | K112349 | 000 |
| 40884521215413 | K112349 | 000 |
| 40884521215420 | K112349 | 000 |
| 20884521134277 | K112349 | 000 |