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Elcam Stopcocks and Manifolds

by Elcam Medical ACAL 510(k)

Active United States

510(k) K141254

Overview

Elcam Stopcocks and Manifolds are medical devices used for fluid control in various applications. These devices are manufactured by Elcam Medical ACAL and are designed for use in general hospital settings.

The device is supplied as a Class II medical device with FDA 510(k) clearance (K141254) and is registered under product code FMG. The device is available in multiple configurations and is manufactured in Israel.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK141254 Date30 Jul 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0155-2022 FDA Class II initiated 10 May 2018

    Product has a lack of sterility assurance

Specification

510(k)

510(k) Number
FDA Product Code
FMG
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Elcam Medical ACAL

See all devices from Elcam Medical ACAL →

Questions

  • What are Elcam Stopcocks and Manifolds used for?

    Elcam Stopcocks and Manifolds are medical devices designed for fluid control in various applications within general hospital settings. They help regulate the flow of fluids in medical procedures.

  • How are Elcam Stopcocks and Manifolds supplied?

    The device is supplied as a Class II medical device with FDA 510(k) clearance (K141254) and is registered under product code FMG. It is manufactured in Israel by Elcam Medical ACAL.

  • What regulatory approvals does the Elcam Stopcock and Manifold have?

    The device has FDA 510(k) clearance (K141254) and is classified as a Class II medical device. It is registered under product code FMG and is intended for use in general hospital settings.

  • Are there different configurations available for the Elcam Stopcocks and Manifolds?

    Yes, the device is available in multiple configurations to suit various fluid control needs in different medical applications. The specific configurations would depend on the requirements of the clinical setting.