免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

SLI內視鏡探針，SLI DENT 裸纖維，SLI HO 裸纖維，SLI HCS 裸纖維，SLI 横向射纖維

K 號：K151855 · 2016-04-15

申請人Surgical Laser Incorporated
決定日期2016-04-15
產品代碼GEX
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Laser Incorporated. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K151855. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber?

SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Surgical Laser Incorporated. The 510(k) number is K151855.

When did SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber receive FDA 510(k) clearance?

SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber received FDA 510(k) clearance on 2016-04-15, under 510(k) number K151855.

Who is the listed applicant for SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber?

The FDA 510(k) record lists Surgical Laser Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber?

The FDA product code for SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber is GEX. This falls under the Gastroenterology category.

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：GEX）

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。

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro 系列Fotona D.O.O.K241973SmartIPL_NI 系統Lumenis Be, Ltd.K261047牙科二極雷射設備（雷射筆）Guilin Kevin Peter Technology Co., Ltd.K261817二極雷射治療系統（PZ-BDT67-01，PZ-BDT67-02）Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED治療設備（QLXY-01）Beijing Nubway S&T Co., Ltd.

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。

↑