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FDA 510(k)

吸水泵（SU-90）

K号: K260892 · 2026-05-14

申请人Shenzhen HugeMed Medical Technical Development Co., Ltd.
决定日期2026-05-14
产品代码BTA
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Suction Pump (SU-90) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260892. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Suction Pump (SU-90)?

Suction Pump (SU-90) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K260892.

When did Suction Pump (SU-90) receive FDA 510(k) clearance?

Suction Pump (SU-90) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260892.

Who is the listed applicant for Suction Pump (SU-90)?

The FDA 510(k) record lists Shenzhen HugeMed Medical Technical Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Suction Pump (SU-90)?

The FDA product code for Suction Pump (SU-90) is BTA.

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

列明Shenzhen HugeMed Medical Technical Development Co., Ltd.为申报人的其他记录

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。

K250695一次性输尿管导管鞘K241444胆胰管内窥镜系统K240374输尿管肾镜系统K232435鼻咽喉镜系统K231497胆道镜系统K231118膀胱镜系统

查看所有 8 个设备 →

相关器械（代码：BTA）

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。

K253629Momcozy 鼻吸器 (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby 鼻吸器（BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021）Shenzhen Root Innovation Technology Co., Ltd.K260473电动鼻吸器（BC027, BC030, BC033, BC035, BC035B）Shenzhen Kingboom Technology Co., Ltd.K253107电动鼻吸器 (DT10 和 DT50, DX80, DX85, DX86 和 DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147电动鼻吸器（BC026, BC025, BC023, BC028, BC029, BC036）Shenzhen Kingboom Technology Co., Ltd.K251450Baby 鼻吸器（BN002）；Baby 鼻吸器（BN006）；Baby 鼻吸器（BN007）；Baby 鼻吸器（BN008）；Baby 鼻吸器（BN009）Shenzhen Desida Technology Co., Ltd.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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