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FDA 510(k)

Wound Geni NPWT System

K-Number: K254019 · 2026-05-04

ApplicantBechtel Medical, Inc.
Decision Date2026-05-04
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Wound Geni NPWT System is the device name listed in this FDA 510(k) record. The listed applicant is Bechtel Medical, Inc.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) number K254019. 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 Wound Geni NPWT System?

Wound Geni NPWT System is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Bechtel Medical, Inc.. The 510(k) number is K254019.

When did Wound Geni NPWT System receive FDA 510(k) clearance?

Wound Geni NPWT System received FDA 510(k) clearance on 2026-05-04, under 510(k) number K254019.

Who is the listed applicant for Wound Geni NPWT System?

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

What is the FDA product code for Wound Geni NPWT System?

The FDA product code for Wound Geni NPWT System is OMP.

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 MedicalK253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryDeroyal Industries, 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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