FDA 510(k)

PICO 7Y 單次使用負壓創口治療系統

K 號：K182323 · 2019-01-18

決定日期2019-01-18

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

PICO 7Y Single Use Negative Pressure Wound Therapy System 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 2019-01-18 under 510(k) number K182323. 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 PICO 7Y Single Use Negative Pressure Wound Therapy System?

PICO 7Y Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K182323.

When did PICO 7Y Single Use Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PICO 7Y Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182323.

Who is the listed applicant for PICO 7Y Single Use Negative Pressure Wound Therapy System?

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 PICO 7Y Single Use Negative Pressure Wound Therapy System?

The FDA product code for PICO 7Y Single Use Negative Pressure Wound Therapy System is OMP.

其他以 Smith & Nephew Medical Limited 為申請人之記錄

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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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