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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K242211
Device Name PUMA-G Pediatric System
Applicant
Coaptech, Inc.
101 W. Dickman St.
Suite 700
Baltimore,  MD  21230
Applicant Contact Jack Kent
Correspondent
Coaptech, Inc.
101 W. Dickman St.
Suite 700
Baltimore,  MD  21230
Correspondent Contact Jack Kent
Regulation Number876.5980
Classification Product Code
KGC  
Date Received07/29/2024
Decision Date 04/29/2025
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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