FDA.reportPublic FDA data

510(k) K221356

Device
Wee Bell
Applicant
Wee Medical
510(k) number
K221356
Product code
HFX
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-02
Date received
2022-05-10
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
No

Applicant Contact#

Contact
D Preston Smith
Address
6800 Baum Dr. Knoxville TN US 37919 37919

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HFX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251687Konig Bell Circumcision ClampMedline Industries, LP2026-02-25
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