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Gettig Guard

by Gettig Pharmaceutical Instrument Co.

510(k) K000455

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 NumberK000455 Date19 Apr 2000ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Gettig Guard is a medical device classified under product code FMI, which corresponds to the regulation 21 CFR 880.5570. It is designed for use within a general hospital setting.

This device is documented under FDA 510(k) clearance number K000455. It was determined to be substantially equivalent by the FDA on April 19, 2000.

Other devices from Gettig Pharmaceutical Instrument Co.

Questions

AI-generated answers, 27 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 Gettig Guard?

    The Gettig Guard is a medical device specifically designed for use within a general hospital setting. It is classified under product code FMI and regulation 21 CFR 880.5570.

  • What is the regulatory status of this device?

    The Gettig Guard is documented under FDA 510(k) clearance number K000455. It was determined to be substantially equivalent by the FDA on April 19, 2000, following a traditional submission process.

  • Who is the manufacturer of the Gettig Guard?

    The device is manufactured by the Gettig Pharmaceutical Instrument Co., located at 55 Northern Blvd., Suite 200, Great Neck, NY 11021.