AngioSystems Drape 5061

by Angiosystems, Incorporated

AngioSystems Drape 5061 is a Class I device made by Angiosystems, Incorporated, cleared under FDA 510(k) K905462 on 6 Feb 1991 and listed in FDA GUDID since 15 Aug 2018 (UDI-DI 00816611022924), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00816611022924 UDI-DI	Date15 Aug 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK905462	Date6 Feb 1991Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00816611022924
FDA 510(k) database 510(k) number K905462

Across registries

2 registries list this device

FDA 510(k) K905462 decided 6 Feb 1991 Active
FDA GUDID UDI-DI 00816611022924 listed 15 Aug 2018 Listed

Timeline

2 dated events

6 Feb 1991 Cleared FDA 510(k) K905462
15 Aug 2018 Listed FDA GUDID 00816611022924

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: AngioSystems Drape
Generic name: General surgical procedure kit, medicated
Model / reference: 5061

Primary DI / UDI-DI: 00816611022924
510(k) Number: K905462
FDA product code: LRP
GMDN term: General surgical procedure kit, medicated

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

Other devices from Angiosystems, Incorporated

See all devices from Angiosystems, Incorporated →

Properties

Supplied sterile
Single use
Lot / batch number
Expiration date

Other properties (11, all answered No)