UNO Negative Pressure Wound Therapy System
K-Number: K161599 · 2017-04-06
ApplicantGenadyne Biotechnologies, Inc.
Decision Date2017-04-06
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
UNO Negative Pressure Wound Therapy System is a medical device manufactured by Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2017-04-06 under approval number K161599. 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 UNO Negative Pressure Wound Therapy System?
UNO Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-04-06. It is manufactured by Genadyne Biotechnologies, Inc.. The 510(k) number is K161599.
When was UNO Negative Pressure Wound Therapy System approved by the FDA?
UNO Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-04-06, under approval number K161599.
What company makes UNO Negative Pressure Wound Therapy System?
UNO Negative Pressure Wound Therapy System is manufactured by Genadyne Biotechnologies, Inc..
What is the FDA product code for UNO Negative Pressure Wound Therapy System?
The FDA product code for UNO Negative Pressure Wound Therapy System is OMP.
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Other Devices by Genadyne Biotechnologies, Inc.
K180840UNO Negative Pressure Wound Therapy System
K221891UNO Negative Pressure Wound Therapy System
K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
K221888Genadyne Hybrid Foam Dressings
K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
K233614Genadyne DUO NPWT
Related Devices (Code: OMP)
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K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC
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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.