FDA 510(k)

CM005 标准 (CM005)；CM004 迷你 (CM004)

K号: K233458 · 2024-07-15

决定日期2024-07-15

产品代码MPN

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决定实质等同

器械摘要

CM005 Standard (CM005); CM004 Mini (CM004) is the device name listed in this FDA 510(k) record. The listed applicant is Connexicon Medical , Ltd.. It received FDA 510(k) clearance on 2024-07-15 under 510(k) number K233458. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CM005 Standard (CM005); CM004 Mini (CM004)?

CM005 Standard (CM005); CM004 Mini (CM004) is a medical device that received FDA 510(k) clearance on 2024-07-15. The listed applicant is Connexicon Medical , Ltd.. The 510(k) number is K233458.

When did CM005 Standard (CM005); CM004 Mini (CM004) receive FDA 510(k) clearance?

CM005 Standard (CM005); CM004 Mini (CM004) received FDA 510(k) clearance on 2024-07-15, under 510(k) number K233458.

Who is the listed applicant for CM005 Standard (CM005); CM004 Mini (CM004)?

The FDA 510(k) record lists Connexicon Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CM005 Standard (CM005); CM004 Mini (CM004)?

The FDA product code for CM005 Standard (CM005); CM004 Mini (CM004) is MPN.

列明Connexicon Medical , 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。

K233460CM00622 LINC 皮肤闭合系统 (CM00622 LINC)

相关器械（代码：MPN）

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。

K243990BondEase 2 表面皮肤粘合剂Optmed, Inc.K250950CUTIVA™局部皮肤粘合剂（RM1700）；CUTIVA™ PLUS皮肤闭合系统（RM1739）Okapi Medical, LLC Dba Resivant Medical K234114CUTIVA™局部皮肤粘合剂（RM-1700）；CUTIVA™ PLUS皮肤闭合系统（RM-1739）Okapi Medical, LLC Dba Resivant Medical K230981Meriglu局部皮肤粘合剂M/s. Meril Endo Surgery Private Limited.K212246Exofin 精密笔Chemence Medical, Inc.K200264Exofin 高粘度局部皮肤粘合剂Chemence Medical, Inc.

官方来源

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