Vygon Ams-100
Vygon Ams-100 is a Class II device made by Vygon Corp., cleared under FDA 510(k) K012157 on 11 Sep 2001 and listed in FDA GUDID since 3 Aug 2016 (UDI-DI 08498840000694), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08498840000694 | Date3 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012157 | Date11 Sep 2001 | StatusActive |
Official records
- AccessGUDID record 08498840000694
- FDA 510(k) database K012157
Across registries
- FDA 510(k) K012157 decided 11 Sep 2001 Active
- FDA GUDID UDI-DI 08498840000694 listed 3 Aug 2016 Listed
Recalls
-
- Terminated Z-0682-2018
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
Timeline
- Cleared FDA 510(k) K012157
- Listed FDA GUDID 08498840000694
- Recall initiated FDA recalls Z-0682-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vygon
- Generic name
- Intravenous line stopcock
- Model / Ref / Catalog
- AMS-100
- Primary DI / UDI-DI
- 08498840000694
- 510(k) Number
- FDA product code
- FMG
- GMDN term
- Intravenous line stopcock
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Intravenous line stopcock.