The following data is part of a premarket notification filed by Covidien Llc with the FDA for Versaone Fascial Closure System Bladed Trocar, Versaone Fascial Closure System Bladeless Trocar, Versaone Fascial Closure System Optical Trocar.
| Device ID | K163654 |
| 510k Number | K163654 |
| Device Name: | VersaOne Fascial Closure System Bladed Trocar, VersaOne Fascial Closure System Bladeless Trocar, VersaOne Fascial Closure System Optical Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Covidien Llc 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Gary Lemere |
| Correspondent | Gary Lemere Covidien Llc 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 | 2016-12-23 |
| Decision Date | 2017-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521678709 | K163654 | 000 |
| 20884521678702 | K163654 | 000 |
| 20884521678719 | K163654 | 000 |