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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 K260646
Device Name RENASYS EDGE (66803126)
Applicant
Smith & Nephew Medical, Ltd.
101 Hessle Rd.
Hull,  GB HU3 2BN
Applicant Contact Chelsea Baker
Correspondent
Smith & Nephew Medical, Ltd.
101 Hessle Rd.
Hull,  GB HU3 2BN
Correspondent Contact Chelsea Baker
Regulation Number878.4780
Classification Product Code
OMP  
Date Received02/27/2026
Decision Date 05/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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