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FDA 510(k)

SleeveLUX 24 眼镜/肛门镜 (P2001)；SleeveLUX 16 眼镜/肛门镜 (P2002)

K号: K250645 · 2025-10-09

申请人Haemoband Surgical, Ltd.
决定日期2025-10-09
产品代码FER
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：FER）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242668Gastro Concepts 空气辅助Gastro Concepts, LLCK230439WellCare 眼镜式内窥镜Well Care (Wuhan) Medical Technology Co., Ltd.K200021应用医疗内窥镜Applied Medical ResourcesK171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.

官方来源

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