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Aneriod Gauze

by Abco Dealers, Inc.

510(k) K812932

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812932 Date2 Dec 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Aneriod Gauze is a sterile, non-adherent dressing designed for wound care and hemostasis. It is intended to protect wounds while absorbing exudate without adhering to the tissue, thereby reducing trauma during dressing changes. The material is structured to provide a moist environment that supports wound healing while minimizing infection risk.

The device is supplied as a single-use, sterile product and is classified under FDA regulation 870.1435 as a Class II medical device. It is intended for use in clinical settings such as hospitals and surgical environments, where it is applied directly to wounds to maintain a clean, protected surface. No MRI safety information is specified, and the product is distributed under the product code DXG with an FDA 510(k) clearance (K812932) granted in 1981.

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