Male Circumcision Kits:Rapideclamp

FDA 510(k) K142163 · Medicfit Technology Sdn Bhd

Substantially Equivalent

510(k) numberK142163

Submission

Device name
Male Circumcision Kits:Rapideclamp
Applicant
Medicfit Technology Sdn Bhd
Great Neck, NY, US
Received
August 6, 2014
Decision date
April 20, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code HFX

510(k)DeviceApplicantDecision
K251687Konig Bell Circumcision ClampHFX · Traditional Medline Industries, LP02/25/2026SE
K221356Wee BellHFX · Traditional Wee Medical02/02/2023SE
K212911Konig Mogen ClampHFX · Traditional Medline Industries, Inc.11/18/2022SE
K151095Circumplast Circumcision DeviceHFX · Traditional Novadien Healthcare09/18/2015SE
K131373ShangringHFX · Special Wuhu Snnda Medical Treatment Appliance Technology06/25/2013SE
K121789ShangringHFX · Traditional Wuhu Snna Medical Treatment Appliance Technology C08/03/2012SE
K103695Prepex SystemHFX · Traditional Circ Medtech01/10/2012SE
K100916Medicon Mogen ClampHFX · Traditional Medicon EG12/06/2010SE
K061539Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional Clinical Innovations, LLC09/20/2007SE
K063429GMD Universal Circumcision Clamp, Model 200HFX · Traditional Generic Medical Device, Inc.01/17/2007SE

Questions and answers

When was Male Circumcision Kits:Rapideclamp cleared by the FDA?

Male Circumcision Kits:Rapideclamp (K142163) received a 510(k) decision of Substantially Equivalent on April 20, 2015, 257 days after the submission was received.

What is the product code of K142163?

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