Vacuson 40 4227-115

Vacuson 40 4227-115 is a Class II device made by Nouvag AG, cleared under FDA 510(k) K042943 on 17 Dec 2004 and listed in FDA GUDID since 21 Aug 2018 (UDI-DI ENOU42271150), 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	NumberENOU42271150 UDI-DI	Date21 Aug 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK042943	Date17 Dec 2004Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K042943

Across registries

2 registries list this device

FDA 510(k) K042943 decided 17 Dec 2004 Active
FDA GUDID UDI-DI ENOU42271150 listed 21 Aug 2018 Listed

Timeline

2 dated events

17 Dec 2004 Cleared FDA 510(k) K042943
21 Aug 2018 Listed FDA GUDID ENOU42271150

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Vacuson 40
Generic name: Surgical suction pump
Model / reference: 4227-115

Primary DI / UDI-DI: ENOU42271150
510(k) Number: K042943
FDA product code: BTA
GMDN term: Surgical suction pump

Device class: Class II
Regulation number: 878.4780
GUDID distribution status: In Commercial Distribution

Other devices from Nouvag AG

See all devices from Nouvag AG →

Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)