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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 K223388
Device Name Invia® Integrated Dressing
Applicant
Medela AG
Lättichstrasse 4b
Baar,  CH 6340
Applicant Contact Judith Bernardo
Correspondent
Hyman, Phelps, & Mcnamara
700 Thirteenth St. NW
Washington,  DC  20005
Correspondent Contact Adrienne Lenz
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/07/2022
Decision Date 07/07/2023
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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