神经缠绕（07-DW-001-TAB）
K号: K242113 · 2025-04-02
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决定日期2025-04-02
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
Nerve Wrap (07-DW-001-TAB) is the device name listed in this FDA 510(k) record. The listed applicant is Biocircuit Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K242113. 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 Nerve Wrap (07-DW-001-TAB)?
Nerve Wrap (07-DW-001-TAB) is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Biocircuit Technologies, Inc.. The 510(k) number is K242113.
When did Nerve Wrap (07-DW-001-TAB) receive FDA 510(k) clearance?
Nerve Wrap (07-DW-001-TAB) received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242113.
Who is the listed applicant for Nerve Wrap (07-DW-001-TAB)?
The FDA 510(k) record lists Biocircuit Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nerve Wrap (07-DW-001-TAB)?
The FDA product code for Nerve Wrap (07-DW-001-TAB) is JXI.
相关临床试验
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。
列明Biocircuit Technologies, Inc.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。
相关器械（代码：JXI）
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。
K260245SILKBridgeKLISBio S.r.l.K253363NeuroSpan 桥Auxilium Biotechnologies, Inc.K251505VersaCoat 神经保护器（VTP-44G2）；VersaCoat 神经保护器（VTP-12G1）Alafair BiosciencesK251175VersaWrap 神经保护器（VTP-2201）；VersaWrap 神经保护器（VTP-1201）Alafair BiosciencesK243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.K233322Mochida神经袖Mochida Pharmaceutical Co., Ltd.
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。
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