The following data is part of a premarket notification filed by Covidien with the FDA for Versaone Bladed Trocar 5mm.
| Device ID | K152149 |
| 510k Number | K152149 |
| Device Name: | VersaOne Bladed Trocar 5mm |
| 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 | 2015-08-03 |
| Decision Date | 2016-01-22 |
| Summary: | summary |