Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
K-Number: K210107 · 2022-06-01
ApplicantGenadyne Biotechnologies, Inc.
Decision Date2022-06-01
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System is a medical device manufactured by Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2022-06-01 under approval number K210107. 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 Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System?
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2022-06-01. It is manufactured by Genadyne Biotechnologies, Inc.. The 510(k) number is K210107.
When was Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System approved by the FDA?
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2022-06-01, under approval number K210107.
What company makes Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System?
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System is manufactured by Genadyne Biotechnologies, Inc..
What is the FDA product code for Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System?
The FDA product code for Genadyne UNO Plus (UNO+) 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.