VS3-Ne 174-0001
VS3-Ne 174-0001 is a Class II device made by Visionsense Ltd., cleared under FDA 510(k) K131434 on 16 Jul 2013 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 18130400103199), 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 | Number18130400103199 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131434 | Date16 Jul 2013 | StatusActive |
Official records
- AccessGUDID record 18130400103199
- FDA 510(k) database K131434
- FDA 510(k) database K123467
Across registries
- FDA 510(k) K131434 decided 16 Jul 2013 Active
- FDA GUDID UDI-DI 18130400103199 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K123467
- Cleared FDA 510(k) K131434
- Listed FDA GUDID 18130400103199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VS3-Ne
- Generic name
- Endoscope video camera
- Model / Ref / Catalog
- 174-0001
- Primary DI / UDI-DI
- 18130400103199
- FDA product code
- GWG, GCJ
- GMDN term
- Endoscope video camera
- Device class
- Class II
- Regulation number
- 882.1480, 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Hydrogen Peroxide
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