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Omi Retractable Saftey Syringe, Various

by Omi Manufacturing Pty., Ltd.

510(k) K060971

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 NumberK060971 Date24 Oct 2006ClearedStatusActive

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  • Withdrawn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
MEG
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Omi Retractable Safety Syringe, Various is a syringe, antistick device designed to reduce the risk of needlestick injuries through a retractable needle mechanism. It is classified as a Class II medical device under FDA regulation 880.5860 and has been determined to be substantially equivalent to a legally marketed predicate device.

The device is supplied in various sizes and configurations as indicated by the 'Various' designation in the product name. It is intended for use in general hospital settings and is authorized under FDA 510(k) clearance K060971. The device is non-sterile unless otherwise specified by the manufacturer's labeling, and its reusability, MRI safety, and storage conditions are not detailed in the provided data.

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