FDA 510(k)

NEXA NPWT System

K-Number: K241515 · 2024-07-26

Decision Date2024-07-26

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NEXA NPWT System is a medical device manufactured by Nexa Medical Limited. It received FDA 510(k) clearance on 2024-07-26 under approval number K241515. 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 NPWT System?

NEXA NPWT System is a medical device that received FDA 510(k) clearance on 2024-07-26. It is manufactured by Nexa Medical Limited. The 510(k) number is K241515.

When was NEXA NPWT System approved by the FDA?

NEXA NPWT System received FDA 510(k) clearance on 2024-07-26, under approval number K241515.

What company makes NEXA NPWT System?

NEXA NPWT System is manufactured by Nexa Medical Limited.

What is the FDA product code for NEXA NPWT System?

The FDA product code for NEXA NPWT System is OMP.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.