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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 K161128
Device Name Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
Applicant
Medela AG
Lattichstrasse 4b
Baar,  CH 6341
Applicant Contact Markus Butler
Correspondent
Pathway Regulatory Consulting, LLC
W324 S3649 County Rd. E
Dousman,  WI  53118
Correspondent Contact Adrienne Lenz
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/21/2016
Decision Date 12/01/2016
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
Recalls CDRH Recalls
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