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Saf-T-Syringe/Saf-T-Needle

by Safety Medical International, Incorporated

510(k) K051762

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 NumberK051762 Date23 Sep 2005ClearedStatusActive

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  • Withdrawn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 Saf-T-Syringe/Saf-T-Needle is a syringe, specifically an antistick syringe. It is a medical device used for injecting or withdrawing fluids from the body.

The device is supplied with various registration numbers, including 3012461127, 3022699058, and others, and is classified under regulation number 880.5860. It is used in a general hospital setting and has been cleared by the FDA under the traditional clearance type with the decision code SESE.

Other devices from Safety Medical International, Incorporated

Questions

AI-generated answers, 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.

  • What is the Saf-T-Syringe used for?

    The Saf-T-Syringe is used for injecting or withdrawing fluids from the body, specifically in a general hospital setting.

  • Is the Saf-T-Syringe sterile?

    The device data does not explicitly state the sterility of the Saf-T-Syringe, but it is intended for use in a hospital setting where sterility is crucial.

  • What are the registration numbers for the Saf-T-Syringe?

    The Saf-T-Syringe has multiple registration numbers, including 3012461127, 3022699058, and others, as listed in the device data.

  • Is the Saf-T-Syringe a single-use or reusable device?

    The device data does not specify whether the Saf-T-Syringe is single-use or reusable, but its intended use in a hospital setting may imply single-use.

  • What is the regulatory classification of the Saf-T-Syringe?

    The Saf-T-Syringe is classified under regulation number 880.5860 and has been cleared by the FDA under the traditional clearance type with the decision code SESE.