The following data is part of a premarket notification filed by Covidien with the FDA for Versaone Reusable Positioning Trocar System.
| Device ID | K201805 |
| 510k Number | K201805 |
| Device Name: | VersaOne Reusable Positioning Trocar System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Stephanie Wilde |
| Correspondent | Stephanie Wilde Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-01 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521794426 | K201805 | 000 |
| 10884521784031 | K201805 | 000 |
| 10884521784048 | K201805 | 000 |
| 10884521784055 | K201805 | 000 |
| 10884521784062 | K201805 | 000 |
| 10884521784079 | K201805 | 000 |
| 20884521785813 | K201805 | 000 |
| 20884521785820 | K201805 | 000 |
| 20884521785837 | K201805 | 000 |
| 20884521785844 | K201805 | 000 |
| 20884521785851 | K201805 | 000 |
| 20884521794433 | K201805 | 000 |
| 10884521784024 | K201805 | 000 |