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Med-Lok Safety Needle

by Sta-Med, LLC

510(k) K103781

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 · Special NumberK103781 Date8 Feb 2011ClearedStatusActive

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  • Withdrawn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, 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 Med-Lok Safety Needle is a Class 2 medical device designed for aspirations and injections of fluids. It features an integrated needle protection mechanism that covers the needle after use to help prevent needle sticks.

This device is supplied as a single-use product and is intended for general hospital settings. It received FDA 510(k) clearance through the Special pathway with product code MEG and is regulated under number 880.5860.

Other devices from Sta-Med, LLC

  • Med-Lok

    Class II

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 Med-Lok Safety Needle used for?

    The Med-Lok Safety Needle is designed for aspirations and injections of fluids in general hospital settings. It features an integrated needle protection mechanism that covers the needle after use to help prevent needle sticks.

  • Is the Med-Lok Safety Needle single-use or reusable?

    The Med-Lok Safety Needle is supplied as a single-use product and is not intended for reuse. This helps maintain sterility and ensures the safety mechanism functions properly after each use.

  • What regulatory approvals does the Med-Lok Safety Needle have?

    The Med-Lok Safety Needle received FDA 510(k) clearance through the Special pathway with product code MEG and is regulated under number 880.5860. It is classified as a Class 2 medical device.

  • What sizes or models of the Med-Lok Safety Needle are available?

    The device data does not specify available sizes or models for the Med-Lok Safety Needle. For detailed information about available configurations, please contact the manufacturer directly.