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

Negative Pressure Wound Therapy Powered Suction Pump

Medela AG

The following data is part of a premarket notification filed by Medela Ag with the FDA for 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.

Pre-market Notification Details

Device IDK161128
510k NumberK161128
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
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Medela AG Lattichstrasse 4b Baar Zug,  CH 6341
ContactMarkus Butler
CorrespondentAdrienne Lenz
Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman,  WI  53118
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-21
Decision Date2016-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07612367053174 K161128 000
07612367053167 K161128 000
07612367052849 K161128 000
07612367051248 K161128 000

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