FDA 510(k) Application Details - K221356

Device Classification Name	Clamp, Circumcision   More FDA Info for this Device
510(K) Number	K221356
Device Name	Clamp, Circumcision
Applicant	wee MEDICAL 6800 Baum Drive Knoxville,, TN 37919 US Other 510(k) Applications for this Company
Contact	D Preston Smith Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2022
Decision Date	02/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review