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FDA 510(k)

SanAgile® 超声手术高级便携式控制器 (SA10)；SanAgile® 超声手术高级解剖器 (SASD14)；SanAgile® 超声手术高级解剖器 (SASD23)；SanAgile® 超声手术高级解剖器 (SASD36)；SanAgile® 超声手术高级解剖器 (SASD45)

K号: K242894 · 2025-06-18

申请人Shanghai Saints Sages Surgical Co., Ltd.
决定日期2025-06-18
产品代码LFL
决定实质等同

器械摘要

SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Saints Sages Surgical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K242894. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常见问题

What is the SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)?

SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Shanghai Saints Sages Surgical Co., Ltd.. The 510(k) number is K242894.

When did SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) receive FDA 510(k) clearance?

SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) received FDA 510(k) clearance on 2025-06-18, under 510(k) number K242894.

Who is the listed applicant for SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)?

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

What is the FDA product code for SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)?

The FDA product code for SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) is LFL.

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：LFL）

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。

K261448neXus 超声手术吸引器系统Misonix, LLCK251162CUSA® Clarity超声手术吸引器系统Integra LifeSciences CorporationK243930Sonopet iQ 超声波吸引器系统 (5500-050-000)Stryker InstrumentsK241700Tenex 2代系统Trice Medical, Inc.K240493CUSA® Clarity超声手术吸引器系统Integra LifeSciences CorporationK233036超声波手术系统Hunan Handlike Minimally Invasive Surgery 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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