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Acu-Guard

by Acuderm, Inc.

510(k) K915000

Acu-Guard is a Class II device made by Acuderm, Inc., cleared under FDA 510(k) K915000 on 27 Jan 1992, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915000 Date27 Jan 1992ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEX
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Devices cleared under K915000

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K915000
UDI-DISize and differences
ACU-GUARD 0ADG51
ACUDERM, INC.
0ADG5100814105020852 —On the market
ACU-GUARD 0ADG51S
ACUDERM, INC.
0ADG51S00814105020876 —On the market
ACU-GUARD 0ADG52
ACUDERM, INC.
0ADG5200814105020869 —On the market
ACU-GUARD ADG51
ACUDERM, INC.
ADG5110814105020859 —On the market
ACU-GUARD ADG51S
ACUDERM, INC.
ADG51S10814105020873 —On the market
ACU-GUARD ADG52
ACUDERM, INC.
ADG5210814105020866 —On the market

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. →