Avance Solo Negative Pressure Wound Therapy (NPWT) System
K-Number: K203369 · 2021-07-01
ApplicantMolnlycke Health Care Us, LLC
Decision Date2021-07-01
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Avance Solo Negative Pressure Wound Therapy (NPWT) System is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2021-07-01 under approval number K203369. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Avance Solo Negative Pressure Wound Therapy (NPWT) System?
Avance Solo Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2021-07-01. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K203369.
When was Avance Solo Negative Pressure Wound Therapy (NPWT) System approved by the FDA?
Avance Solo Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2021-07-01, under approval number K203369.
What company makes Avance Solo Negative Pressure Wound Therapy (NPWT) System?
Avance Solo Negative Pressure Wound Therapy (NPWT) System is manufactured by Molnlycke Health Care Us, LLC.
What is the FDA product code for Avance Solo Negative Pressure Wound Therapy (NPWT) System?
The FDA product code for Avance Solo Negative Pressure Wound Therapy (NPWT) System is OMP.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.