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FDA 510(k)

NEXA Negative Pressure Wound Therapy System

K-Number: K162610 · 2017-06-08

ApplicantNexa Medical , Ltd.
Decision Date2017-06-08
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEXA Negative Pressure Wound Therapy System is a medical device manufactured by Nexa Medical , Ltd.. It received FDA 510(k) clearance on 2017-06-08 under approval number K162610. 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 NEXA Negative Pressure Wound Therapy System?

NEXA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Nexa Medical , Ltd.. The 510(k) number is K162610.

When was NEXA Negative Pressure Wound Therapy System approved by the FDA?

NEXA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-06-08, under approval number K162610.

What company makes NEXA Negative Pressure Wound Therapy System?

NEXA Negative Pressure Wound Therapy System is manufactured by Nexa Medical , Ltd..

What is the FDA product code for NEXA Negative Pressure Wound Therapy System?

The FDA product code for NEXA Negative Pressure Wound Therapy System is OMP.

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Related PubMed Literature

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Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia 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 SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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.

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