VersaOne B12LGF
by Covidien LP
VersaOne B12LGF is a Class II device made by Covidien LP, cleared under FDA 510(k) K151548 on 2 Jul 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521539891), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521539891 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151548 | Date2 Jul 2015 | StatusActive |
Official records
- AccessGUDID record 10884521539891
- FDA 510(k) database K151548
Across registries
- FDA 510(k) K151548 decided 2 Jul 2015 Active
- FDA GUDID UDI-DI 10884521539891 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K151548
- Listed FDA GUDID 10884521539891
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VersaOne
- Generic name
- Laparoscopic multi-instrument access port, single-use
- Model / reference
- B12LGF
- Primary DI / UDI-DI
- 10884521539891
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Laparoscopic multi-instrument access port, single-use
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 12 Millimeter
Similar devices in this category
Other devices filed under Laparoscopic multi-instrument access port, single-use.
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- EntryGuide 430022 by Intuitive Surgical, Inc.
- GelPOINT Path Transanal Access Platform CNB12 by APPLIED MEDICAL RESOURCES CORP.
- 432701 by Intuitive Surgical, Inc.
- VersaOne RC11STS by Covidien LP
- VersaOne RC8STS by Covidien LP