HFX — Clamp, Circumcision Class II

FDA Device Classification

Classification Details

Product Code
HFX
Device Class
Class II
Regulation Number
884.4530
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251687medline industriesKonig Bell Circumcision ClampFebruary 25, 2026
K221356wee medicalWee BellFebruary 2, 2023
K212911medline industriesKonig Mogen ClampNovember 18, 2022
K151095novadien healthcareCircumplast Circumcision DeviceSeptember 18, 2015
K142163medicfit technologyMALE CIRCUMCISION KITS:RAPIDECLAMPApril 20, 2015
K131373wuhu snnda medical treatment appliance technologySHANGRINGJune 25, 2013
K121789wuhu snna medical treatment appliance technology cSHANGRINGAugust 3, 2012
K103695circ medtechPREPEX SYSTEMJanuary 10, 2012
K100916medicon egMEDICON MOGEN CLAMPDecember 6, 2010
K061539clinical innovationsGOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICESeptember 20, 2007
K063429generic medical deviceGMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200January 17, 2007
K043533surgical designSURGICAL DESIGN CIRCUMCISION CLAMPApril 1, 2005
K040052fine surgical instrumentFINE SURGICAL CIRCUMCISION CLAMPApril 9, 2004
K032091emergogroupSMART KLAMP VARIOUS BY SIZEMarch 8, 2004
K033403t.s. medicalT.S. MEDICAL CIRCUMCISION CLAMPJanuary 22, 2004
K010867iris surgicalKILEJIAN CIRCUMCISORMay 3, 2001
K974286trinity laboratoriesCIRCUMCISION TRAY, CAT. NO. 70340December 12, 1997
K970282medlineMEDLINE CIRCUMCISION TRAYMarch 6, 1997
K945949vlm surgicalKILEJIAN CIRCUMCISION TEMPLATE [THE DOME]July 25, 1995
K935697cush medical productsCIRCUMCISION TRAYMay 2, 1994