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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K252537
Device Name Rusch SoftSimplastic Foley Catheters
Applicant
Teleflex Medical Sdn. Bhd.
Lot Pt. 2577,
Jalan Perusahaan 4
Kamunting,  MY 34000
Applicant Contact Yuvaanesswary Nallappan
Correspondent
Teleflex Medical Sdn. Bhd.
Lot Pt. 2577,
Jalan Perusahaan 4
Kamunting,  MY 34000
Correspondent Contact Yuvaanesswary Nallappan
Regulation Number876.5130
Classification Product Code
EZL  
Date Received08/12/2025
Decision Date 01/20/2026
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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