The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As United States with the FDA for Autosuture Versaport Plus Bladless Trocar; Bladeless Trocar.
| Device ID | K081169 |
| 510k Number | K081169 |
| Device Name: | AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Tim Lohnes |
| Correspondent | Tim Lohnes COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE 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 | 2008-04-24 |
| Decision Date | 2008-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521076508 | K081169 | 000 |
| 20884521073194 | K081169 | 000 |
| 20884521073286 | K081169 | 000 |
| 20884521073958 | K081169 | 000 |
| 20884521076478 | K081169 | 000 |
| 20884521076485 | K081169 | 000 |
| 20884521076522 | K081169 | 000 |
| 20884521076546 | K081169 | 000 |
| 20884521076492 | K081169 | 000 |
| 20884521076225 | K081169 | 000 |
| 20884521075723 | K081169 | 000 |