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FDA 510(k)

Kobold Fletcher型号串联和椭圆形施用器套装，Kobold Henschke型号串联和椭圆形施用器套装，Kobold 阴道圆柱施用器套装，Kobold Miami圆柱施用器套装

K号: K160610 · 2017-02-13

申请人Kobold, LLC
决定日期2017-02-13
产品代码JAQ
咨询委员会RA
决定实质等同

器械摘要

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set is the device name listed in this FDA 510(k) record. The listed applicant is Kobold, LLC. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K160610. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set?

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Kobold, LLC. The 510(k) number is K160610.

When did Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set receive FDA 510(k) clearance?

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set received FDA 510(k) clearance on 2017-02-13, under 510(k) number K160610.

Who is the listed applicant for Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set?

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

What is the FDA product code for Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set?

The FDA product code for Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set is JAQ.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Kobold, LLC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。

K170203系统，应用器，放射性核素，遥控

相关器械（代码：JAQ）

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。

K262383LumenCare AzureNucletron B.V.K252717MAASTRO 直肠应用器套装Varian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884引导阿胡斯应用器套装Varian Medical SystemsK250299CT/ MR 连续和椭圆形套装Varian Medical Systems, Inc.K250289腔内/间质系统Varian Medical Systems

官方来源

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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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