FDA 510(k)

NovoSorb® MTX

K 號：K242149 · 2025-03-05

決定日期2025-03-05

產品代碼QSZ

決定相當於

器材摘要

NovoSorb® MTX 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 2025-03-05 under 510(k) number K242149. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常見問題

What is the NovoSorb® MTX?

NovoSorb® MTX is a medical device that received FDA 510(k) clearance on 2025-03-05. The listed applicant is Polynovo Biomaterials Pty, Ltd.. The 510(k) number is K242149.

When did NovoSorb® MTX receive FDA 510(k) clearance?

NovoSorb® MTX received FDA 510(k) clearance on 2025-03-05, under 510(k) number K242149.

Who is the listed applicant for NovoSorb® MTX?

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® MTX?

The FDA product code for NovoSorb® MTX 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 K221686新索爾布馬特里克斯 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.K241660SiOxD® 瘘管組織Sioxmed, LLC K232847SiOxD 瘘傷組織Sioxmed, LLC

官方來源

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