Umbilical Cord Clamp

FDA 510(k) K994367 · Medical Sales Co.

Substantially Equivalent

510(k) numberK994367

Submission

Device name
Umbilical Cord Clamp
Applicant
Medical Sales Co.
North Salt Lake, UT, US
Received
December 27, 1999
Decision date
March 17, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HFW – Clamp, Umbilical
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFW

510(k)DeviceApplicantDecision
K041332Joey Clamp Opening ToolHFW · Traditional Maternus, Inc.06/25/2004SE
K033846Kaen Yih Umbilical Cord ClampHFW · Traditional Kaen Yih Enterprise Co., Ltd.03/11/2004SE
K020718Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterileHFW · Traditional Precision Dynamics Corp.06/03/2002SE
K021055Busse Umbilical Cord Clamp CutterHFW · Traditional Busse Hospital Disposables, Inc.04/29/2002SE
K012917Dynarex Umbilical Cord Lamp, Models 6833 and 6833-BHFW · Traditional Dynarex Corp.11/28/2001SE
K011621Koala Clamp, Koala Clamp and CutterHFW · Traditional Maternus, Inc.08/10/2001SE
K010695Koala ClampHFW · Traditional Maternus, Inc.05/03/2001SE
K010835Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp…HFW · Traditional Busse Hospital Disposables, Inc.04/30/2001SE
K000227UmbicutHFW · Traditional Pollak (Intl.), Ltd.04/27/2000SE
K994263Securline Umbilical Cord Clamp Clipper #3540HFW · Traditional Precision Dynamics Corp.01/24/2000SE

Questions and answers

When was Umbilical Cord Clamp cleared by the FDA?

Umbilical Cord Clamp (K994367) received a 510(k) decision of Substantially Equivalent on March 17, 2000, 81 days after the submission was received.

What is the product code of K994367?

The FDA product code is HFW – Clamp, Umbilical, a Class II (moderate risk) device regulated under 21 CFR 884.4530.