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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K253263
Device Name ConvaVAC™ Negative Pressure Wound Therapy System
Applicant
Convatec Limited, Gdc Building
First Ave.
Deeside Industrial Park
Deeside, Flintshire,  GB CH5 2NU
Applicant Contact Michelle Campbell
Correspondent
Convatec Limited, Gdc Building
First Ave.
Deeside Industrial Park
Deeside, Flintshire,  GB CH5 2NU
Correspondent Contact Michelle Campbell
Regulation Number878.4780
Classification Product Code
OMP  
Subsequent Product Code
FRO  
Date Received09/29/2025
Decision Date 06/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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