FDA 510(k)

Sphincterotome

K号: K201121 · 2021-02-05

决定日期2021-02-05

产品代码KNS

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决定实质等同

器械摘要

Sphincterotome 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 2021-02-05 under 510(k) number K201121. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sphincterotome?

Sphincterotome is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K201121.

When did Sphincterotome receive FDA 510(k) clearance?

Sphincterotome received FDA 510(k) clearance on 2021-02-05, under 510(k) number K201121.

Who is the listed applicant for Sphincterotome?

FDA 510(k)记录将杭州AGS医械科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Sphincterotome?

The FDA product code for Sphincterotome is KNS.

列明Hangzhou AGS MedTech Co., Ltd.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。

K254069血液夹（511系列，543系列）K253393一次性球囊扩张导管（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内镜水泵 K222421Sphincterotome

查看所有 19 个设备 →

相关器械（代码：KNS）

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。

K262460Rezum系统Boston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388征服水蒸气消融装置Francis Medical, Inc.K252889一次性3腔针刀V（KD-V441M，KD-V451M）Olympus Medical Systems Corporation K250945一次性预装括约肌刀V（远端导丝引导）（KD-VC600系列）；一次性括约肌刀V（远端导丝引导）（KD-VC400系列）；一次性三腔括约肌刀（KD-V系列）；一次性三腔括约肌刀（KD系列）Olympus Medical Systems Corp.K250351一次性电外科刀 (KD-612L, KD-612U)；一次性电外科刀 (KD-620UR)；一次性电外科刀 (KD-650L, KD-650U)Olympus Medical Systems Corporation

官方来源

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