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Acu-Evac Adpack

by Acuderm, Inc.

Acu-Evac Adpack is a Class II device made by Acuderm, Inc., cleared under FDA 510(k) K930043 on 9 Feb 1994 and listed in FDA GUDID since 21 Oct 2026 (UDI-DI 00814105021743), active as of 2 Nov 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 2 Nov 2026

Documents

510(k) K930043

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814105021743 UDI-DI Date21 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK930043 Date9 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K930043 decided 9 Feb 1994 Active
  • FDA GUDID UDI-DI 00814105021743 listed 21 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K930043
  2. Listed FDA GUDID 00814105021743

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Acu-Evac
Generic name
Surgical plume evacuation system
Model / reference
ADPACK
Primary DI / UDI-DI
00814105021743
510(k) Number
FDA product code
FYD
GMDN term
Surgical plume evacuation system
Device class
Class II
Regulation number
878.5070
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K930043)

and 8 more cleared under K930043

Similar devices

Other devices filed under FDA product code FYD (Apparatus, Exhaust, Surgical).

Other devices from Acuderm, Inc.

See all devices from Acuderm, Inc. →

Properties

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