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QFC Umbilical Clamp

by Qfc Industries 510(k)

Active United States

510(k) K963889

Overview

An umbilical clamp is an instrument used to compress the umbilical cord. This device is classified as a Clamp, Umbilical under FDA product code HFW and is regulated under 21 CFR 884.4530.

It received FDA 510(k) clearance K963889 on April 18, 1997, as substantially equivalent to a predicate device. The device is supplied by Qfc Industries and is intended for use in obstetrics and gynecology settings.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963889 Date18 Apr 1997ClearedStatusActive

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
HFW
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the QFC UMBILICAL CLAMP used for?

    The QFC UMBILICAL CLAMP is an instrument designed to compress the umbilical cord. It is intended for use in obstetrics and gynecology settings, as stated in the device description and advisory committee classification.

  • How is the QFC UMBILICAL CLAMP supplied?

    The device is supplied by Qfc Industries. The manufacturer's address is listed as 2405 Forest Park Blvd., Fort Worth, TX 76110, USA. No specific packaging or distribution details are provided in the data.

  • Is the QFC UMBILICAL CLAMP sterile or single-use?

    The provided data does not contain any information regarding sterility, reprocessing, or whether the device is intended for single use or reuse. These details are not present in the specifications or description fields.

  • What sizes and models are available for the QFC UMBILICAL CLAMP?

    The device data does not specify any available sizes, models, or variations of the QFC UMBILICAL CLAMP. Only the single device name is listed without dimensional or model variants.

  • What are the storage requirements for the QFC UMBILICAL CLAMP?

    There is no information in the provided data regarding storage conditions, temperature ranges, or shelf life for the QFC UMBILICAL CLAMP.