FDA 510(k)

Fusion OMNI Sphincterotome

K号: K172288 · 2018-04-17

申请人Wilson-Cook Medical Inc./Cook Endoscopy

决定日期2018-04-17

产品代码KNS

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Fusion OMNI Sphincterotome is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K172288. 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 Fusion OMNI Sphincterotome?

Fusion OMNI Sphincterotome is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K172288.

When did Fusion OMNI Sphincterotome receive FDA 510(k) clearance?

Fusion OMNI Sphincterotome received FDA 510(k) clearance on 2018-04-17, under 510(k) number K172288.

Who is the listed applicant for Fusion OMNI Sphincterotome?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fusion OMNI Sphincterotome?

The FDA product code for Fusion OMNI Sphincterotome is KNS.

列明Wilson-Cook Medical Inc./Cook Endoscopy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。

K190829胃肠道注射针（VIN，LDVI，DVI和MHI）K172665Classic Cotton Cannulatome®、CannulaTome II® 双腔括约肌切开刀、Cotton CannulaTome II® PC、UTS® 超细锥括约肌切开刀、Tri-Tome pc® 三腔括约肌切开刀、Howell D.A.S.H.® 括约肌切开刀带DomeTip®、Billroth II 括约肌切开刀、Soehendra® BII 括约肌切开刀、型号ACU-1和ACU-1-VL活动线缆 K171993Zimmon针刀乳头刀 K171607Bronchi and Gastrointestinal Cytology Brush

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

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