FDA 510(k)

VersaCoat 神经保护器（VTP-44G2）；VersaCoat 神经保护器（VTP-12G1）

K号: K251505 · 2025-07-22

决定日期2025-07-22

产品代码JXI

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K251505. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)?

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Alafair Biosciences. The 510(k) number is K251505.

When did VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) receive FDA 510(k) clearance?

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) received FDA 510(k) clearance on 2025-07-22, under 510(k) number K251505.

Who is the listed applicant for VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)?

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

What is the FDA product code for VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)?

The FDA product code for VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) is JXI.

列明Alafair Biosciences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。

K251655VersaCoat 腱保护器（VTP-44G2）；VersaCoat 腱保护器（VTP-12G1）K251175VersaWrap 神经保护器（VTP-2201）；VersaWrap 神经保护器（VTP-1201）

官方来源

在 FDA 数据库中查看 →

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。