FDA.report

510(k) K251687

Device
Konig Bell Circumcision Clamp
Applicant
Medline Industries, LP
510(k) number
K251687
Product code
HFX
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-25
Date received
2025-06-02
Regulation
884.4530
Classification name
Clamp, Circumcision
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jennifer Mason
Address
Three Lakes Dr. Northfiled IL US 60093 60093

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HFX

510(k)DeviceApplicantDecision date
K221356Wee BellWee Medical2023-02-02
K212911Konig Mogen ClampMedline Industries, Inc.2022-11-18
K151095Circumplast Circumcision DeviceNovadien Healthcare2015-09-18
K142163MALE CIRCUMCISION KITS:RAPIDECLAMPMedicfit Technology Sdn Bhd2015-04-20
K131373SHANGRINGWuhu Snnda Medical Treatment Appliance Technology2013-06-25
K121789SHANGRINGWuhu Snna Medical Treatment Appliance Technology C2012-08-03
K103695PREPEX SYSTEMCirc Medtech2012-01-10
K100916MEDICON MOGEN CLAMPMedicon EG2010-12-06
K061539GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICEClinical Innovations, LLC2007-09-20
K063429GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200Generic Medical Device, Inc.2007-01-17
K043533SURGICAL DESIGN CIRCUMCISION CLAMPSurgical Design, Inc.2005-04-01
K040052FINE SURGICAL CIRCUMCISION CLAMPFine Surgical Instrument Corp.2004-04-09
K032091SMART KLAMP VARIOUS BY SIZEEmergogroup, Inc.2004-03-08
K033403T.S. MEDICAL CIRCUMCISION CLAMPT.S. Medical2004-01-22
K010867KILEJIAN CIRCUMCISORIris Surgical, LLC2001-05-03