FDA 510(k)

TeslaTome雙極肛門斷術器，Tesla雙極活動電纜

K 號：K192339 · 2020-01-30

決定日期2020-01-30

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

TeslaTome Bipolar Sphincterotome, Tesla Bipolar 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 2020-01-30 under 510(k) number K192339. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord?

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K192339.

When did TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord receive FDA 510(k) clearance?

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord received FDA 510(k) clearance on 2020-01-30, under 510(k) number K192339.

Who is the listed applicant for TeslaTome Bipolar Sphincterotome, Tesla Bipolar 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 Bipolar Active Cord?

The FDA product code for TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is KNS.

其他以 Wilson-Cook Medical, Inc. 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。

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相關器械（代碼：KNS）

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。

K262460Rezum系統Boston Scientific K260962括約肌切除器Taewoong Medical Co., Ltd.K252388征服水蒸氣消融設備Francis Medical, Inc.K252889單次使用3 lumens針刀V型（KD-V441M，KD-V451M）Olympus Medical Systems Corporation K250945單次使用預裝式括約肌斷刀V型（遠端導絲導引）(KD-VC600系列)；單次使用括約肌斷刀V型（遠端導絲導引）(KD-VC400系列)；單次使用3腔括約肌斷刀(KD-V系列)；一次性三腔括約肌斷刀(KD系列)Olympus Medical Systems Corp.K250351單次使用電外科刀（KD-612L，KD-612U）；單次使用電外科刀（KD-620UR）；單次使用電外科刀（KD-650L，KD-650U）Olympus Medical Systems Corporation

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