免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

傷口基因NPWT系統

K 號：K254019 · 2026-05-04

申請人Bechtel Medical, Inc.
決定日期2026-05-04
產品代碼OMP
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：OMP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 負壓傷口治療系統Convatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 內容器 500-mL (CPC-500)Cork MedicalK253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑