Voyant 开放融合设备
K号: K180699 · 2018-04-13
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决定日期2018-04-13
产品代码GEI
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Voyant Open Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K180699. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Voyant Open Fusion Device?
Voyant Open Fusion Device is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K180699.
When did Voyant Open Fusion Device receive FDA 510(k) clearance?
Voyant Open Fusion Device received FDA 510(k) clearance on 2018-04-13, under 510(k) number K180699.
Who is the listed applicant for Voyant Open Fusion Device?
The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Voyant Open Fusion Device?
The FDA product code for Voyant Open Fusion Device is GEI.
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Applied Medical Resources Corporation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。
K260982Alexis 照明伤口保护器-拉钩，柔性，特小（cl312）；Alexis 照明伤口保护器-拉钩，柔性，小（cl301）；Alexis 照明伤口保护器-拉钩，柔性，中（cl302）；Alexis 照明伤口保护器-拉钩，柔性，大（cl303）；Alexis 照明伤口保护器-拉钩，刚性，小（cl401）；Alexis 照明伤口保护器-拉钩，刚性，中（cl402）；Alexis 照明伤口保护器-拉钩，刚性，大（cl403）K253531Alexis® 照明伤口保护器-拉钩，刚性，中（CL402）；Alexis® 照明伤口保护器-拉钩，柔性，中（CL302）K252412Voyant® 电外科发生器（EA030/电外科发生器）K232880Inzii Ripstop 可重部署回收系统K222284Voyant Maryland融合设备（单步激活，EB212，EB213，EB214）K220969GelPOINT V-Path Vaginal Access System
相关器械（代码：GEI）
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。
K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLCK261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker InstrumentsK261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364艾利安谜团射频设备Ellian CorpK253859Scarlet Pro（Scarlet Pro）VIOL 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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