FDA 510(k)

RF蒸氣系統

K 號：K213627 · 2021-12-17

決定日期2021-12-17

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

RF Vapor System is the device name listed in this FDA 510(k) record. The listed applicant is Aqua Medical, Inc.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K213627. 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 RF Vapor System?

RF Vapor System is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Aqua Medical, Inc.. The 510(k) number is K213627.

When did RF Vapor System receive FDA 510(k) clearance?

RF Vapor System received FDA 510(k) clearance on 2021-12-17, under 510(k) number K213627.

Who is the listed applicant for RF Vapor System?

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

What is the FDA product code for RF Vapor System?

The FDA product code for RF Vapor System is KNS.

其他以 Aqua 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。

K251226Aqua Medical RF 蒸氣消融系統 K241271Aqua Medical RF 蒸氣消融系統 K211282Aqua Medical RF 蒸氣系統 K183595Aqua Medical RF 蒸氣系統

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

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