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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 K190060
Device Name Urethrotech UCD
Applicant
Urethrotech
24 Garth Road
Kingston upon Thames,  GB KT2 5NY
Applicant Contact Daniela Andrich
Correspondent
Smith Associates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number876.5130
Classification Product Code
EZL  
Date Received01/11/2019
Decision Date 10/04/2019
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
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