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Male Luer Lock Plug

by American Viggo

510(k) K771339

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 NumberK771339 Date2 Aug 1977ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 21 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 Male Luer Lock Plug is a medical device used in the administration of intravascular medical procedures. It is classified as a Set, Administration, Intravascular device. The device is used in general hospital settings. It is a type of connector used in medical tubing systems.

The Male Luer Lock Plug is supplied as a single-use device and is available in various sizes. It is made by American Viggo and has been granted FDA 510K clearance with the decision code SESE. The device is stored and used in accordance with the manufacturer's instructions and is subject to regulation under 880.5440. It has a product code of FPA and a K number of K771339.

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