FDA 510(k)

InviaEase 負壓創傷治療（NPWT）系統

K 號：K214112 · 2022-07-26

決定日期2022-07-26

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

Invia Ease Negative Pressure Wound Therapy (NPWT) System is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2022-07-26 under 510(k) number K214112. 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 Invia Ease Negative Pressure Wound Therapy (NPWT) System?

Invia Ease Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2022-07-26. The listed applicant is Medela AG. The 510(k) number is K214112.

When did Invia Ease Negative Pressure Wound Therapy (NPWT) System receive FDA 510(k) clearance?

Invia Ease Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2022-07-26, under 510(k) number K214112.

Who is the listed applicant for Invia Ease Negative Pressure Wound Therapy (NPWT) System?

The FDA 510(k) record lists Medela AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Invia Ease Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for Invia Ease Negative Pressure Wound Therapy (NPWT) System is OMP.

其他以 Medela AG 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。

K251377魔法InBra K223388Invia® 整合式敷料 K191653Freestyle Flex K182191Invia腹部敷料組 K180415Invia 白泡沫 NPWT K172145Invia 泡沫敷料組合包含 FitPad，Invia Motion 負壓創傷治療系統（Invia Motion - Endure，Invia Motion – 120 天，Invia Motion – 60 天，Invia Motion – 30 天，Invia Motion – 15 天，Invia Motion – 7 天），Invia Liberty 負壓創傷治療系統，Invia 纱布敷料組合包含 FitPad

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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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