The following data is part of a premarket notification filed by Covidien with the FDA for Versaone Bladed Trocar, Versaone Bladeless Trocar.
| Device ID | K151548 |
| 510k Number | K151548 |
| Device Name: | VersaOne Bladed Trocar, VersaOne Bladeless Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Trang Huynh |
| Correspondent | Trang Huynh COVIDIEN 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 | 2015-06-09 |
| Decision Date | 2015-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521717708 | K151548 | 000 |
| 20884521539874 | K151548 | 000 |
| 20884521678733 | K151548 | 000 |
| 20884521539898 | K151548 | 000 |
| 20884521539881 | K151548 | 000 |
| 20884521539867 | K151548 | 000 |
| 20884521539850 | K151548 | 000 |
| 20884521539843 | K151548 | 000 |
| 20884521539836 | K151548 | 000 |
| 20884521539829 | K151548 | 000 |
| 20884521539904 | K151548 | 000 |
| 20884521717715 | K151548 | 000 |
| 20884521678726 | K151548 | 000 |
| 20884521546919 | K151548 | 000 |
| 20884521546902 | K151548 | 000 |
| 20884521546896 | K151548 | 000 |
| 20884521546889 | K151548 | 000 |
| 20884521546872 | K151548 | 000 |
| 20884521546865 | K151548 | 000 |
| 20884521546858 | K151548 | 000 |
| 20884521546841 | K151548 | 000 |
| 20884521539812 | K151548 | 000 |