FDA 510(k)

Teslatome 双极肛门括约肌刀；Tesla BiCord 主动线缆

K号: K243568 · 2025-01-17

决定日期2025-01-17

产品代码KNS

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决定实质等同

器械摘要

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K243568. 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 Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord?

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K243568.

When did Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord receive FDA 510(k) clearance?

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord received FDA 510(k) clearance on 2025-01-17, under 510(k) number K243568.

Who is the listed applicant for Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord?

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

What is the FDA product code for Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord?

The FDA product code for Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord is KNS.

列明Wilson-Cook Medical, Inc.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。

K253302Hemospray 内镜止血夹 (HEMO-[X])K213356Entuit PEG，Entuit PEGJ K212323Instinct Plus Endoscopic Clipping Device K201322Entuit 鼻空肠喂养管 K200972Hemospray 内镜止血夹 K200247Fusion Quattro Extraction Balloon

查看所有 32 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

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