FDA 510(k)

RENASYS WOUND+ 內含 AIRLOCK 技術的敷料組合包

K 號：K251826 · 2025-09-11

決定日期2025-09-11

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

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K251826. 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 RENASYS WOUND+ Dressing Kit with AIRLOCK Technology?

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K251826.

When did RENASYS WOUND+ Dressing Kit with AIRLOCK Technology receive FDA 510(k) clearance?

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology received FDA 510(k) clearance on 2025-09-11, under 510(k) number K251826.

Who is the listed applicant for RENASYS WOUND+ Dressing Kit with AIRLOCK Technology?

FDA 510(k) 記錄將史密斯與內夫公司（Smith & Nephew Medical, Ltd.）列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for RENASYS WOUND+ Dressing Kit with AIRLOCK Technology?

The FDA product code for RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is OMP.

其他以 Smith & Nephew Medical, Ltd. 為申請人之記錄

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）K260646RENASYS EDGE (66803126)K243576RENASYS 泡沫傷口敷料組合包含 AIRLOCK 技術和柔軟端口；RENASYS 絹布傷口敷料組合包含 AIRLOCK 技術和柔軟端口 K231939Renasys 邊緣 K190756碘柔膠 K190730碘吸收器

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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 Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 內容器 500-mL (CPC-500)Cork Medical K254019傷口基因NPWT系統Bechtel Medical, Inc.

官方來源

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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。