FDA 510(k)

RENASYS Touch；RENASYS Y-接頭器

K 號：K181822 · 2019-03-21

決定日期2019-03-21

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 Touch; RENASYS Y-Connector is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-03-21 under 510(k) number K181822. 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 Touch; RENASYS Y-Connector?

RENASYS Touch; RENASYS Y-Connector is a medical device that received FDA 510(k) clearance on 2019-03-21. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K181822.

When did RENASYS Touch; RENASYS Y-Connector receive FDA 510(k) clearance?

RENASYS Touch; RENASYS Y-Connector received FDA 510(k) clearance on 2019-03-21, under 510(k) number K181822.

Who is the listed applicant for RENASYS Touch; RENASYS Y-Connector?

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

What is the FDA product code for RENASYS Touch; RENASYS Y-Connector?

The FDA product code for RENASYS Touch; RENASYS Y-Connector is OMP.

其他以 Smith & Nephew Medical Limited 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。

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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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