FDA 510(k)

Advantage Ultra System，Advantage Fit Ultra System，Lynx Ultra System

K号: K211223 · 2021-07-21

决定日期2021-07-21

产品代码OTN

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决定实质等同

器械摘要

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K211223. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Boston Scientific Corporation. The 510(k) number is K211223.

When did Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System receive FDA 510(k) clearance?

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System received FDA 510(k) clearance on 2021-07-21, under 510(k) number K211223.

Who is the listed applicant for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System?

The FDA product code for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System is OTN.

列明Boston Scientific 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。

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相关器械（代码：OTN）

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。

K231549Advantage Ultra System，Advantage Fit Ultra System，Lynx Ultra SystemBoston Scientific Corporation K222293ArcSP Suprapubic Sling SystemUrocure, LLC K222468ArcTO 经闭式吊带系统Urocure, LLC K211975Desara TV EZ 3.0 系统，Desara Blue TV EZ 3.0 系统，Desara TV EZ 2.7 系统，Desara Blue TV EZ 2.7 系统Caldera Medical, Inc.K210087Athena 手术 RMUS 系统Athena Surgical, LLC K201686GYNECARE TVT™系统，GYNECARE TVT™腹部导引器系统，GYNECARE TVT™导引器和导管导引器，GYNECARE TVT EXACT™排尿系统和套管，GYNECARE TVT™闭孔系统、传递器和翼形导引器，GYNECARE TVT ABBREVO™排尿系统和传递器、翼形导引器ETHICON, Inc.

官方来源

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