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Microcare

by American Imex

510(k) K926326

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926326 Date1 Jun 1993ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Microcare(Tm)
510(k) Number
FDA Product Code
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The Microcare is a medical device categorized under the neurology advisory committee. It is identified by product code GZJ and is designed for use within neurological clinical applications.

This device received FDA 510(k) clearance on June 1, 1993, under reference number K926326. It is manufactured by American Imex, based in Irvine, California.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What is the intended use of the Microcare device?

    The Microcare is designed for use within neurological clinical applications. It is officially categorized under the neurology advisory committee and identified by product code GZJ.

  • What is the regulatory status of the Microcare?

    The Microcare received FDA 510(k) clearance on June 1, 1993. This clearance was granted under reference number K926326 following a traditional submission process.

  • Who is the manufacturer of this device?

    The Microcare is manufactured by American Imex, which is based in Irvine, California. The company contact for this device is listed as Joan Fong.