Oasis MV-Y344

by American Health Service Sales Corporation

Oasis MV-Y344 is a Class II device made by American Health Service Sales Corporation, cleared under FDA 510(k) K130737 on 14 Jan 2014 and listed in FDA GUDID since 14 Jan 2016 (UDI-DI B031MVY3440), 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	NumberB031MVY3440 UDI-DI	Date14 Jan 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK130737	Date14 Jan 2014Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K130737

Across registries

2 registries list this device

FDA 510(k) K130737 decided 14 Jan 2014 Active
FDA GUDID UDI-DI B031MVY3440 listed 14 Jan 2016 Listed

Timeline

2 dated events

14 Jan 2014 Cleared FDA 510(k) K130737
14 Jan 2016 Listed FDA GUDID B031MVY3440

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Oasis
Generic name: Poliglecaprone suture
Model / reference: MV-Y344

Primary DI / UDI-DI: B031MVY3440
510(k) Number: K130737
FDA product code: GAM
GMDN term: Poliglecaprone suture

Device class: Class II
Regulation number: 878.4493
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)