FDA 510(k)

Aqua Medical RF 蒸氣消融系統

K 號：K241271 · 2024-12-12

決定日期2024-12-12

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

Aqua Medical RF Vapor Ablation 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 2024-12-12 under 510(k) number K241271. 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 Aqua Medical RF Vapor Ablation System?

Aqua Medical RF Vapor Ablation System is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Aqua Medical, Inc.. The 510(k) number is K241271.

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

Aqua Medical RF Vapor Ablation System received FDA 510(k) clearance on 2024-12-12, under 510(k) number K241271.

Who is the listed applicant for Aqua Medical RF Vapor Ablation 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 Aqua Medical RF Vapor Ablation System?

The FDA product code for Aqua Medical RF Vapor Ablation 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 K213627RF蒸氣系統 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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