FDA 510(k)

Prevena Restor 適應形態敷料

K 號：K220660 · 2022-07-01

決定日期2022-07-01

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

Prevena Restor Adapti-Form Dressing is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare Business Group. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K220660. 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 Prevena Restor Adapti-Form Dressing?

Prevena Restor Adapti-Form Dressing is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is 3M Healthcare Business Group. The 510(k) number is K220660.

When did Prevena Restor Adapti-Form Dressing receive FDA 510(k) clearance?

Prevena Restor Adapti-Form Dressing received FDA 510(k) clearance on 2022-07-01, under 510(k) number K220660.

Who is the listed applicant for Prevena Restor Adapti-Form Dressing?

The FDA 510(k) record lists 3M Healthcare Business Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prevena Restor Adapti-Form Dressing?

The FDA product code for Prevena Restor Adapti-Form Dressing is OMP.

其他以 3M Healthcare Business Group 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。

K2215853M V.A.C. Veraflo 清洁选择敷料套装，3M Veraflo 清洁选择完整敷料套装 K210135PROMOGRAN PRISMA 矩陣，小型敷料，PROMOGRAN PRISMA 矩陣，大型敷料 K2115213M Veraflo 清洁选择完整敷料套装（中型敷料套装：VFCCC05MD，大型敷料套装：VFCCC05LG）K212320Dermatac™ 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術-小號（5入），Dermatac 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術 -小號（10入），Dermatac 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術 -中號（5入），Dermatac 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術 -中號（10入），Dermatac 折邊與V.A.C. Granufoam 敷料，配備SensaT.R.A.C. 技術- 大號（5入）

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

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。