FDA 510(k)

新索爾布馬特里克斯

K 號：K221686 · 2022-09-15

決定日期2022-09-15

產品代碼QSZ

決定相當於

器材摘要

NovoSorb Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Polynovo Biomaterials Pty, Ltd.. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K221686. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常見問題

What is the NovoSorb Matrix?

NovoSorb Matrix is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Polynovo Biomaterials Pty, Ltd.. The 510(k) number is K221686.

When did NovoSorb Matrix receive FDA 510(k) clearance?

NovoSorb Matrix received FDA 510(k) clearance on 2022-09-15, under 510(k) number K221686.

Who is the listed applicant for NovoSorb Matrix?

The FDA 510(k) record lists Polynovo Biomaterials Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovoSorb Matrix?

The FDA product code for NovoSorb Matrix is QSZ.

其他以 Polynovo Biomaterials Pty, 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。

K251567新索爾BTM K242149NovoSorb® MTX K172140NovoSorb BTM 黏膜敷料（2cm x 2cm）、NovoSorb BTM 黏膜敷料（10cm x 10cm）、NovoSorb BTM 黏膜敷料（10cm x 20cm）、NovoSorb BTM 黏膜敷料（20cm x 40cm）

相關器械（代碼：QSZ）

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。

K261311HYALOMATRIXAnika Therapeutics, Inc.K254256LOUFUCON® 黃金創傷組織Huizhou Foryou Medical Devices Co., Ltd.K260020Redermo 瘘傷組織Beijing Kreate Medical Co., Ltd.K251567新索爾BTMPolynovo Biomaterials Pty, Ltd.K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.K241660SiOxD® 瘘管組織Sioxmed, LLC

官方來源

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