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FDA 510(k)

SleeveLUX 24 頸顎鏡/肛鏡 (P2001)；SleeveLUX 16 頸顎鏡/肛鏡 (P2002)

K 號：K250645 · 2025-10-09

申請人Haemoband Surgical, Ltd.
決定日期2025-10-09
產品代碼FER
諮詢委員會GU
決定相當於

器材摘要

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) is the device name listed in this FDA 510(k) record. The listed applicant is Haemoband Surgical, Ltd.. It received FDA 510(k) clearance on 2025-10-09 under 510(k) number K250645. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)?

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Haemoband Surgical, Ltd.. The 510(k) number is K250645.

When did SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) receive FDA 510(k) clearance?

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K250645.

Who is the listed applicant for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)?

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

What is the FDA product code for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)?

The FDA product code for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) is FER.

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：FER）

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。

K242668Gastro Concepts 氣動輔助設備Gastro Concepts, LLCK230439WellCare 鼻鏡Well Care (Wuhan) Medical Technology Co., Ltd.K200021Applied Medical 鏡頭Applied Medical ResourcesK171701GelPOINT 腹腔鏡通路平台Applied Medical Resources Corp.

官方來源

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