Harwill Medical U-Klip Umbilical Clamp

FDA 510(k) K983204 · Harwill Medical (Pty) , Ltd.

Substantially Equivalent

510(k) numberK983204

Submission

Device name
Harwill Medical U-Klip Umbilical Clamp
Applicant
Harwill Medical (Pty) , Ltd.
Crofton, MD, US
Received
September 14, 1998
Decision date
February 26, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K994367Umbilical Cord ClampHFW · Traditional Medical Sales Co.03/17/2000SE

More from Medical Sales Co.

510(k)DeviceDecision
K992618RespalertBZH · Traditional 10/29/1999SE
K983202Harwill Medical Cervitula Cervical SpatulaHHT · Traditional 03/15/1999SE
K980550Whistle WatchBZH · Traditional 08/27/1998SE

Questions and answers

When was Harwill Medical U-Klip Umbilical Clamp cleared by the FDA?

Harwill Medical U-Klip Umbilical Clamp (K983204) received a 510(k) decision of Substantially Equivalent on February 26, 1999, 165 days after the submission was received.

What is the product code of K983204?

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