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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 K261291
Device Name Nisus NPWT Canister 500-mL (CPC-500)
Applicant
Cork Medical
8000 Castleway Dr.
Indianapolis,  IN  46112
Applicant Contact Antonio Williams
Correspondent
Cork Medical
8000 Castleway Dr.
Indianapolis,  IN  46112
Correspondent Contact Antonio Williams
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/20/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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