FDA 510(k)

NovoSorb BTM

K号: K251567 · 2025-06-20

决定日期2025-06-20

产品代码QSZ

决定实质等同

器械摘要

NovoSorb BTM 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 2025-06-20 under 510(k) number K251567. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常见问题

What is the NovoSorb BTM?

NovoSorb BTM is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Polynovo Biomaterials Pty, Ltd.. The 510(k) number is K251567.

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

NovoSorb BTM received FDA 510(k) clearance on 2025-06-20, under 510(k) number K251567.

Who is the listed applicant for NovoSorb BTM?

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 BTM?

The FDA product code for NovoSorb BTM is QSZ.

列明Polynovo Biomaterials Pty, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242149NovoSorb® MTX K221686NovoSorb Matrix K172140NovoSorb BTM 创面敷料（2cm x 2cm），NovoSorb BTM 创面敷料（10cm x 10cm），NovoSorb BTM 创面敷料（10cm x 20cm），NovoSorb BTM 创面敷料（20cm x 40cm）

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。