FDA 510(k)

Voyant® 开放融合设备（EB240/开放融合）

K号: K252740 · 2025-11-04

决定日期2025-11-04

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 (EB240/Open Fusion) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2025-11-04 under 510(k) number K252740. 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 (EB240/Open Fusion)?

Voyant® Open Fusion Device (EB240/Open Fusion) is a medical device that received FDA 510(k) clearance on 2025-11-04. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K252740.

When did Voyant® Open Fusion Device (EB240/Open Fusion) receive FDA 510(k) clearance?

Voyant® Open Fusion Device (EB240/Open Fusion) received FDA 510(k) clearance on 2025-11-04, under 510(k) number K252740.

Who is the listed applicant for Voyant® Open Fusion Device (EB240/Open Fusion)?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant® Open Fusion Device (EB240/Open Fusion)?

The FDA product code for Voyant® Open Fusion Device (EB240/Open Fusion) is GEI.

列明Applied Medical Resources Corp.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。

K252442Kii结构球囊通路系统 K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device K201212Voyant 开放融合设备 K200598Voyant马里兰州融合设备 K193292Voyant 5mm 融合设备，Voyant 马里兰州融合设备 K191294经阴道入路平台

查看所有 11 个设备 →

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, LLC K261959Neptune® 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 Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet 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。