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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K223756
Device Name SimPro™ Now, GentleCath™ Hydrophilic
Applicant
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Laura Sobrin
Correspondent
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Laura Sobrin
Regulation Number876.5130
Classification Product Code
EZD  
Subsequent Product Code
EZC  
Date Received12/15/2022
Decision Date 05/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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