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FDA 510(k)

Sonablate

K 號：K160942 · 2016-12-21

申請人Sonacare Medical, LLC
決定日期2016-12-21
產品代碼PLP
諮詢委員會GU
決定相當於

器材摘要

Sonablate is the device name listed in this FDA 510(k) record. The listed applicant is Sonacare Medical, LLC. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K160942. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sonablate?

Sonablate is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Sonacare Medical, LLC. The 510(k) number is K160942.

When did Sonablate receive FDA 510(k) clearance?

Sonablate received FDA 510(k) clearance on 2016-12-21, under 510(k) number K160942.

Who is the listed applicant for Sonablate?

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

What is the FDA product code for Sonablate?

The FDA product code for Sonablate is PLP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：PLP）

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。

K251910Focal One®Edap Technomed, Inc.K240296塔斯卡普羅系統（Pad-105）Profound Medical, Inc.K231378Exablate 模型 2100V1，Exablate 前列腺系統，Exablate MRgFUS，Exablate 2100V1 型號 3.0Insightec, Ltd.K230692TULSA-PRO系統Profound Medical, Inc.K211858TULSA-PRO系統Profound Medical, Inc.K212150Exablate Prostate SystemInsightec, Inc.

官方來源

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