FDA 510(k)

NerveTape

K号: K233533 · 2024-02-12

决定日期2024-02-12

产品代码JXI

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决定实质等同

器械摘要

NerveTape 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 2024-02-12 under 510(k) number K233533. 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 NerveTape?

NerveTape is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Biocircuit Technologies, Inc.. The 510(k) number is K233533.

When did NerveTape receive FDA 510(k) clearance?

NerveTape received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233533.

Who is the listed applicant for NerveTape?

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 NerveTape?

The FDA product code for NerveTape is JXI.

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。

K242113神经缠绕（07-DW-001-TAB）

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 Biosciences K251175VersaWrap 神经保护器（VTP-2201）；VersaWrap 神经保护器（VTP-1201）Alafair Biosciences K242113神经缠绕（07-DW-001-TAB）Biocircuit Technologies, Inc.K243889Remplir (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.

官方来源

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