The following data is part of a premarket notification filed by Covidien with the FDA for Versaone Bladeless Trocar.
| Device ID | K162584 |
| 510k Number | K162584 |
| Device Name: | VersaOne Bladeless Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN 60 MIDDLETOWN AVE North Haven, CT 06473 |
| Contact | Trang Huynh |
| Correspondent | Trang Huynh COVIDIEN 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 | 2016-09-16 |
| Decision Date | 2016-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521717661 | K162584 | 000 |
| 20884521717678 | K162584 | 000 |
| 20884521593463 | K162584 | 000 |
| 20884521717654 | K162584 | 000 |
| 20884521717647 | K162584 | 000 |
| 20884521593456 | K162584 | 000 |