VELscope VELsheath Vx
VELscope VELsheath Vx (5720) is a Class II device made by Led Dental, Inc., cleared under FDA 510(k) K102083 on 18 Nov 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07540201000032), 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 | Number07540201000032 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102083 | Date18 Nov 2010 | StatusActive |
Official records
- AccessGUDID record 07540201000032
- FDA 510(k) database K102083
Across registries
- FDA 510(k) K102083 decided 18 Nov 2010 Active
- FDA GUDID UDI-DI 07540201000032 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K102083
- Listed FDA GUDID 07540201000032
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VELscope
- Generic name
- Medical equipment handle cover, single-use, non-sterile
- Model / Ref / Catalog
- VELsheath Vx, 5720
- Primary DI / UDI-DI
- 07540201000032
- 510(k) Number
- FDA product code
- NXV
- GMDN term
- Medical equipment handle cover, single-use, non-sterile
- Device class
- Class II
- Regulation number
- 872.6350
- GUDID distribution status
- In Commercial Distribution
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