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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K221356
Device Name Wee Bell
Applicant
Wee Medical
6800 Baum Dr.
Knoxville,  TN  37919
Applicant Contact D Preston Smith
Correspondent
Grace Powers - Powers Regulatory Consulting
2451 Cumberland Pkwy. SE
Suite 3740
Atlanta,  GA  30339
Correspondent Contact Grace Powers
Regulation Number884.4530
Classification Product Code
HFX  
Date Received05/10/2022
Decision Date 02/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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