FDA 510(k)

石子回收氣球

K 號：K200173 · 2020-05-01

決定日期2020-05-01

產品代碼GCA

諮詢委員會GU

決定相當於

器材摘要

Stone Retrieval Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K200173. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stone Retrieval Balloon?

Stone Retrieval Balloon is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K200173.

When did Stone Retrieval Balloon receive FDA 510(k) clearance?

Stone Retrieval Balloon received FDA 510(k) clearance on 2020-05-01, under 510(k) number K200173.

Who is the listed applicant for Stone Retrieval Balloon?

FDA 510(k) 記錄將杭州AGS醫療技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Stone Retrieval Balloon?

The FDA product code for Stone Retrieval Balloon is GCA.

其他以 Hangzhou AGS MedTech Co., Ltd. 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。

K254069血夾（511系列，543系列）K253393單次使用氣球擴張導管（AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019）K252270Hemoclip K252271Hemoclip K241704內視鏡式水泵 K222421括約肌切除器

查看所有 19 項裝置 →

相關器械（代碼：GCA）

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。

K253013一次性石塊回收氣球導管Zhejiang Soudon Medical Technology Co., Ltd.K232752石頭提取氣球（VDK-BAL-23-11/13/15-B，VDK-BAL-23-15/18/20-B，VDK-BAL-23-9/12/15-B，VDK-BAL-23-10/13/16-B，VDK-BAL-23-8.5/11.5/15-B，VDK-BAL-23-12/15/18-B，VDK-BAL-23-11/13/15-C，VDK-BAL-23-15/18/20-C，VDK-BAL-23-9/12/15-C，VDK-BAL-23-10/13/16-C，VDK-BAL-23-8.5/11.5/15-C，VDK-BAL-23-12/15/18-C）Jiangsu Vedkang Medical Science and Technology Co., Ltd.K212582SpyGlass Discover 激光擴張導管Boston Scientific Corporation K210660石子回收氣球導管Anrei Medical (Hangzhou) Co., Ltd.K200247融合四合一抽吸球Wilson-Cook Medical, Inc.K193344三重抽離氣球，多尺寸設計Wilson-Cook Medical, Inc.

官方來源

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