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AngioSystems Cap Cover 6001

by Angiosystems, Incorporated

AngioSystems Cap Cover 6001 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 3 Sep 2018 (UDI-DI 00816611024812), 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

510(k) K905462

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816611024812 UDI-DI Date3 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK905462 Date6 Feb 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K905462 decided 6 Feb 1991 Active
  • FDA GUDID UDI-DI 00816611024812 listed 3 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K905462
  2. Listed FDA GUDID 00816611024812

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AngioSystems Cap Cover
Generic name
Camera cover, single-use
Model / reference
6001
Primary DI / UDI-DI
00816611024812
510(k) Number
FDA product code
LRP
GMDN term
Camera cover, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LRP (Tray, Surgical).

Other devices from Angiosystems, Incorporated

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Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)