FDA 510(k)

MCB單元型號：V10GMCBUS

K 號：K222542 · 2022-09-21

決定日期2022-09-21

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

MCB UNIT Model: V10GMCBUS is the device name listed in this FDA 510(k) record. The listed applicant is Lamidey Noury Medical. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K222542. 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 MCB UNIT Model: V10GMCBUS?

MCB UNIT Model: V10GMCBUS is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Lamidey Noury Medical. The 510(k) number is K222542.

When did MCB UNIT Model: V10GMCBUS receive FDA 510(k) clearance?

MCB UNIT Model: V10GMCBUS received FDA 510(k) clearance on 2022-09-21, under 510(k) number K222542.

Who is the listed applicant for MCB UNIT Model: V10GMCBUS?

The FDA 510(k) record lists Lamidey Noury Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCB UNIT Model: V10GMCBUS?

The FDA product code for MCB UNIT Model: V10GMCBUS is KNS.

其他以 Lamidey Noury Medical 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。

K240504PLASMA EDGE 系統

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

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。