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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 a medical device manufactured by Bechtel Medical, Inc.. It received FDA 510(k) clearance on 2026-05-04 under approval 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. It is manufactured by Bechtel Medical, Inc.. The 510(k) number is K254019.

When was Wound Geni NPWT System approved by the FDA?

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

What company makes Wound Geni NPWT System?

Wound Geni NPWT System is manufactured by Bechtel Medical, Inc..

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

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

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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