Medsci 3% Glutaraldehyde

by Medsci, Inc.

510(k) K974062

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

510(k) K974062↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK974062	Date2 Sep 1998Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K974062
FDA Product Code: MED

Device Class: Class II
Regulation: 21 CFR Part 880.6885
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Medsci 3% Glutaraldehyde is an activated liquid chemical sterilant and high-level disinfectant. It is intended to be used by healthcare practitioners to sterilize or disinfect medical devices.

This product is supplied as a solution with an activator for use in healthcare facilities such as hospitals and offices. It has received FDA 510(k) clearance under K974062.