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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 K153209
Device Name RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
Applicant
Smith & Nephew Medical, Ltd.
101 Hessle Rd.
Hull,  GB HU32BN
Applicant Contact LAURA REYNOLDS
Correspondent
Smith & Nephew, Inc.
970 Lake Carillon Dr.
Suite 110
St Petersburg,  FL  33716
Correspondent Contact LAURA REYNOLDS
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/05/2015
Decision Date 08/04/2016
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 No
Predetermined Change
Control Plan Authorized		 No
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