The following data is part of a premarket notification filed by Covidien with the FDA for Versaone Optical Trocar 15mm, Versaone Bladeless Trocar 15mm.
| Device ID | K160230 |
| 510k Number | K160230 |
| Device Name: | VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm |
| 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 | 2016-02-01 |
| Decision Date | 2016-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521717739 | K160230 | 000 |
| 20884521717722 | K160230 | 000 |
| 20884521548104 | K160230 | 000 |
| 20884521185972 | K160230 | 000 |
| 20884521548098 | K160230 | 000 |