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Acu-Guard ADG51

by Acuderm, Inc.

Acu-Guard ADG51 is a Class II device made by Acuderm, Inc., cleared under FDA 510(k) K915000 on 27 Jan 1992 and listed in FDA GUDID since 3 Jan 2020 (UDI-DI 10814105020859), 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

510(k) K915000

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10814105020859 UDI-DI Date3 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK915000 Date27 Jan 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K915000 decided 27 Jan 1992 Active
  • FDA GUDID UDI-DI 10814105020859 listed 3 Jan 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K915000
  2. Listed FDA GUDID 10814105020859

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Acu-Guard
Generic name
Medical equipment drape, single-use, non-sterile
Model / reference
ADG51
Primary DI / UDI-DI
10814105020859
510(k) Number
FDA product code
GEX
GMDN term
Medical equipment drape, single-use, non-sterile
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical equipment drape, single-use, non-sterile

Cleared under the same submission (K915000)

and 1 more cleared under K915000

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Acuderm, Inc.

  • Acu-Evac Adpack

    Class II

  • Acu-Evac ARMC1

    Class II

  • Acu-Evac Adlpack

    Class II

  • Acu-Punch

    Class IIa

See all devices from Acuderm, Inc. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)