AVELLE Negative Pressure Wound Therapy System
K-Number: K180205 · 2018-10-19
ApplicantConvatec Limited
Decision Date2018-10-19
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AVELLE Negative Pressure Wound Therapy System is a medical device manufactured by Convatec Limited. It received FDA 510(k) clearance on 2018-10-19 under approval number K180205. 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 AVELLE Negative Pressure Wound Therapy System?
AVELLE Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2018-10-19. It is manufactured by Convatec Limited. The 510(k) number is K180205.
When was AVELLE Negative Pressure Wound Therapy System approved by the FDA?
AVELLE Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2018-10-19, under approval number K180205.
What company makes AVELLE Negative Pressure Wound Therapy System?
AVELLE Negative Pressure Wound Therapy System is manufactured by Convatec Limited.
What is the FDA product code for AVELLE Negative Pressure Wound Therapy System?
The FDA product code for AVELLE Negative Pressure Wound Therapy 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.