FDA 510(k)

一次性石塊取出籃

K 號：K201509 · 2020-12-16

決定日期2020-12-16

產品代碼LQR

諮詢委員會GU

決定相當於

器材摘要

Disposable Stone Extraction basket 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 2020-12-16 under 510(k) number K201509. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Stone Extraction basket?

Disposable Stone Extraction basket is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K201509.

When did Disposable Stone Extraction basket receive FDA 510(k) clearance?

Disposable Stone Extraction basket received FDA 510(k) clearance on 2020-12-16, under 510(k) number K201509.

Who is the listed applicant for Disposable Stone Extraction basket?

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 Disposable Stone Extraction basket?

The FDA product code for Disposable Stone Extraction basket is LQR.

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

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相關器械（代碼：LQR）

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。

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官方來源

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