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Exel Three-Way Stopcock

by Exel Intl. 510(k)

Active United States

510(k) K862492

Overview

The device is a stopcock, I.V. set, classified as a Class 2 medical device under the General Hospital medical specialty. It is a three-way stopcock designed for use in intravenous fluid administration systems.

It was cleared by the FDA through the Traditional 510(k) pathway under k-number K862492, with a decision date of September 25, 1986, and is substantially equivalent to a predicate device. The device is supplied non-sterile and intended for single-use, as indicated by its classification and regulatory history, with no claims of sterility or reusability in the provided data.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862492 Date25 Sep 1986ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 Exel Intl.

See all devices from Exel Intl. →

Questions

  • What is the EXEL THREE-WAY STOPCOCK used for?

    The EXEL THREE-WAY STOPCOCK is designed for use in intravenous fluid administration systems as a three-way stopcock, allowing control of fluid flow direction in IV setups.

  • Is the EXEL THREE-WAY STOPCOCK sterile or non-sterile, and is it intended for single-use or reuse?

    The device is supplied non-sterile and intended for single-use, as indicated by its regulatory classification and history, with no claims of sterility or reusability in the provided data.

  • What regulatory pathway was used to clear the EXEL THREE-WAY STOPCOCK, and what is its k-number?

    The device was cleared by the FDA through the Traditional 510(k) pathway under k-number K862492, with a decision date of September 25, 1986, and is substantially equivalent to a predicate device.