FDA 510(k)

Sonata 超声引导经宫颈子宫肌瘤消融系统

K号: K173703 · 2018-08-15

决定日期2018-08-15

产品代码KNF

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决定实质等同

器械摘要

Sonata Sonography-Guided Transcervical Fibroid Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Gynesonics, Inc.. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K173703. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sonata Sonography-Guided Transcervical Fibroid Ablation System?

Sonata Sonography-Guided Transcervical Fibroid Ablation System is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Gynesonics, Inc.. The 510(k) number is K173703.

When did Sonata Sonography-Guided Transcervical Fibroid Ablation System receive FDA 510(k) clearance?

Sonata Sonography-Guided Transcervical Fibroid Ablation System received FDA 510(k) clearance on 2018-08-15, under 510(k) number K173703.

Who is the listed applicant for Sonata Sonography-Guided Transcervical Fibroid Ablation System?

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

What is the FDA product code for Sonata Sonography-Guided Transcervical Fibroid Ablation System?

The FDA product code for Sonata Sonography-Guided Transcervical Fibroid Ablation System is KNF.

列明Gynesonics, Inc.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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