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SSafe Plus Disposable Safety Syringe, 3 cc and 5 cc

by Dolomite Biotech Sdn Bhd

510(k) K070117

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 NumberK070117 Date6 Aug 2007ClearedStatusActive

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  • Withdrawn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, 19 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 SSafe Plus Disposable Safety Syringe is a manual retractable, single-use syringe designed to prevent needle stick injuries and reuse of the needle. It is classified as an antistick syringe, intended for injecting medication or withdrawing fluids from the human body. The device features a retractable mechanism to enhance safety during and after use.

This sterile, non-pyrogenic syringe is intended for single-use only and is not reusable. It is supplied in a disposable format and is classified under FDA regulation 880.5860. The device is authorised under FDA 510(k) clearance (K070117) with a decision date of 2007-08-06, falling under product code MEG and device class II. It is intended for use in general hospital settings.