FDA 510(k) Applications for Medical Device Product Code "HFX"
(Clamp, Circumcision)

FDA 510(k) Number Applicant Device Name Decision Date
K103695 CIRC MEDTECH PREPEX SYSTEM 01/10/2012
K061539 CLINICAL INNOVATIONS, LLC GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE 09/20/2007
K032091 EMERGO GROUP, INC. SMART KLAMP VARIOUS BY SIZE 03/08/2004
K040052 FINE SURGICAL INSTRUMENT CORP. FINE SURGICAL CIRCUMCISION CLAMP 04/09/2004
K063429 GENERIC MEDICAL DEVICE, INC. GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 01/17/2007
K010867 IRIS SURGICAL, LLC KILEJIAN CIRCUMCISOR 05/03/2001
K142163 MEDICFIT TECHNOLOGY SDN BHD MALE CIRCUMCISION KITS:RAPIDECLAMP 04/20/2015
K100916 MEDICON, E.G. MEDICON MOGEN CLAMP 12/06/2010
K970282 MEDLINE MEDLINE CIRCUMCISION TRAY 03/06/1997
K212911 Medline Industries, Inc Konig Mogen Clamp 11/18/2022
K151095 Novadien Healthcare Circumplast Circumcision Device 09/18/2015
K043533 SURGICAL DESIGN, INC. SURGICAL DESIGN CIRCUMCISION CLAMP 04/01/2005
K033403 T.S. MEDICAL T.S. MEDICAL CIRCUMCISION CLAMP 01/22/2004
K974286 TRINITY LABORATORIES, INC. CIRCUMCISION TRAY, CAT. NO. 70340 12/12/1997
K221356 wee MEDICAL Wee Bell 02/02/2023
K121789 WUHU SNNA MEDICAL TREATMENT APPLIANCE TECHNOLOGY C SHANGRING 08/03/2012
K131373 WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY SHANGRING 06/25/2013


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