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Clickzip, Model U-100 Insulin Safety Syringe

by Medical Device Manufacturer (Thailand), Ltd.

510(k) K062780

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 · Abbreviated NumberK062780 Date5 Jan 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  • Withdrawn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
FDA applicant
Medical Device Manufacturer (Thailand) , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a syringe, antistick, designed for the administration of insulin. It is a safety syringe featuring a needle retraction mechanism to help prevent needlestick injuries following use.

It is supplied as a single-use device for subcutaneous injection of U-100 insulin. The device has received FDA 510(k) clearance (K062780) and is classified as a Class II medical device under regulation number 880.5860 with product code MEG.

Other devices from Medical Device Manufacturer (Thailand), Ltd.

Questions

AI-generated answers, 26 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 CLICKZIP Model U-100 Insulin Safety Syringe used for?

    It is designed for the subcutaneous administration of U-100 insulin, featuring a needle retraction mechanism to help prevent needlestick injuries after use.

  • Is the CLICKZIP Model U-100 Insulin Safety Syringe reusable or single-use?

    It is supplied as a single-use device, meaning it is intended for one injection only and should be discarded after use to ensure safety and sterility.

  • How is the CLICKZIP Model U-100 Insulin Safety Syringe supplied?

    It is provided as a sterile, single-use syringe ready for subcutaneous insulin delivery, with no assembly required prior to use.