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Gettig Universal Vial Access Pin

by Gettig Pharmaceutical Instrument Co.

510(k) K041232

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 NumberK041232 Date22 Jul 2004ClearedStatusActive

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  • Withdrawn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
LHI
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Gettig Universal Vial Access Pin is a plastic device designed to pierce the diaphragm of single or multi-dose vials to inject or withdraw fluids without the use of a needle. It consists of a single molded piece containing a luer hub for attachment to a disposable piston syringe and a plastic needle for piercing the vial diaphragm, along with a polypropylene cover for the needle portion.

The device is supplied as a single-use accessory intended for use with standard medication vials in a general hospital setting. It received FDA 510(k) clearance (K041232) on July 22, 2004, under product code LHI and regulation number 880.5440, with a traditional clearance type and no third-party review.

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