Vygon Ams-290

by Vygon Corp. 3 variants

Vygon Ams-290 is a Class II device made by Vygon Corp., cleared under FDA 510(k) K013949 on 27 Mar 2002 and listed in FDA GUDID since 16 Dec 2022 (UDI-DI 00849884006063), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00849884006063 UDI-DI	Date16 Dec 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK013949	Date27 Mar 2002Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00849884006063
FDA 510(k) database 510(k) number K013949

Across registries

2 registries list this device

FDA 510(k) K013949 decided 27 Mar 2002 Active
FDA GUDID UDI-DI 00849884006063 listed 16 Dec 2022 Listed

Timeline

2 dated events

27 Mar 2002 Cleared FDA 510(k) K013949
16 Dec 2022 Listed FDA GUDID 00849884006063

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Vygon
Generic name: Vial/bottle adaptor, non-hermetic
Model / Ref / Catalog: AMS-290

Primary DI / UDI-DI: 00849884006063
510(k) Number: K013949
FDA product code: FPA
GMDN term: Vial/bottle adaptor, non-hermetic

Device class: Class II
Regulation number: 880.5440
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Vial/bottle adaptor, non-hermetic.

Other devices from Vygon Corp.

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Vygon PIP200100T

Class II

See all devices from Vygon Corp. →

Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)