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FDA 510(k)

NEXA™ NPWT System

K-Number: K241515 · 2024-07-26

ApplicantNexa Medical Limited
Decision Date2024-07-26
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEXA™ NPWT System is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Medical Limited. It received FDA 510(k) clearance on 2024-07-26 under 510(k) 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. The listed applicant is Nexa Medical Limited. The 510(k) number is K241515.

When did NEXA™ NPWT System receive FDA 510(k) clearance?

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

Who is the listed applicant for NEXA™ NPWT System?

The FDA 510(k) record lists Nexa Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXA™ NPWT System?

The FDA product code for NEXA™ NPWT System is OMP.

Other records listing Nexa Medical Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162610NEXA Negative Pressure Wound Therapy System

Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

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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