FDA 510(k)

Sonata 超聲導引經頸內子宮肌瘤消融系統

K 號：K173703 · 2018-08-15

決定日期2018-08-15

產品代碼KNF

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

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.

常見問題

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.

其他以 Gynesonics, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250705Sonata經宮腔內子宮肌瘤消融系統 2.2 K240503Sonata經宮腔內子宮肌瘤消融系統 2.2 K233848Sonata經宮腔子宮肌瘤消融系統 2.2 (SONATA2-220)K222304Sonata經宮腔內子宮肌瘤消融系統 2.2 K211535Sonata經宮腔內子宮肌瘤消融系統 2.2 K193516Sonata® 超聲導引經子宮頸內子宮肌瘤消融系統 2.1

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相關器械（代碼：KNF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254303KARL STORZ 超環Karl Storz SE & CO. KG K250705Sonata經宮腔內子宮肌瘤消融系統 2.2Gynesonics, Inc.K240503Sonata經宮腔內子宮肌瘤消融系統 2.2Gynesonics, Inc.K233848Sonata經宮腔子宮肌瘤消融系統 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata經宮腔內子宮肌瘤消融系統 2.2Gynesonics, Inc.K211535Sonata經宮腔內子宮肌瘤消融系統 2.2Gynesonics, Inc.

官方來源

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