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Ongard 3 Quart Sharps Container

by On-Gard Systems, Inc.

510(k) K933274

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 NumberK933274 Date16 May 1994ClearedStatusActive

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  • Withdrawn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
FDA applicant
Ongard Systems, Inc.
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
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 Ongard 3 Quart Sharps Container is a medical device designed for the safe disposal of sharps. It provides a secure enclosure for used needles and other sharp medical instruments to prevent accidental injury.

This device is identified by 510(k) number K933274 and has received FDA 510(k) clearance. It is categorized under the General Hospital advisory committee for use in clinical settings.

Other devices from On-Gard Systems, Inc.

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 primary purpose of the Ongard 3 Quart Sharps Container?

    This device is designed to provide a secure, puncture-resistant enclosure for the disposal of used needles and other sharp medical instruments, helping to prevent accidental injuries in clinical environments.

  • Is this sharps container cleared for use by regulatory authorities?

    Yes, the Ongard 3 Quart Sharps Container has received FDA 510(k) clearance under the number K933274, confirming it has been reviewed and found substantially equivalent for its intended use in clinical settings.

  • In what type of environment is this device intended to be used?

    The device is categorized under the General Hospital advisory committee, indicating it is intended for use within professional clinical settings where the safe management and disposal of medical sharps are required.