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FDA 510(k)

单次使用注射器 Force Max 单次使用注射器 (NM-400L)；单次使用注射器 Force Max 单次使用注射器 (NM-400U)；单次使用注射器 Force Max 单次使用注射器 (NM-400Y)；单次使用注射器 Force Max 单次使用注射器 (NM-401L)

K号: K252247 · 2025-10-16

申请人Olympus Medical Systems Corporation
决定日期2025-10-16
产品代码FBK
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

Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K252247. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)?

Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K252247.

When did Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) receive FDA 510(k) clearance?

Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) received FDA 510(k) clearance on 2025-10-16, under 510(k) number K252247.

Who is the listed applicant for Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)?

FDA 510(k)记录显示，Olympus Medical Systems Corporation为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)?

The FDA product code for Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) is FBK.

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Olympus Medical Systems Corporation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。

K260824胃肠内窥镜 奥林巴斯 GIF-2T1500K260856一次性远端附件 D-201-13404K260401EVIS EUS 超声支气管纤维内窥镜 OLYMPUS BF-UCP190F（BF-UCP190F）K261183EVIS EUS 超声胃肠内窥镜（Olympus GF-UE190）K261260HD 摄像头 OLYMPUS CH-S200-08-LBK252050一次性活检镊 FB-211D, FB-221D, FB-231D, FB-241D

查看所有 36 个设备 →

相关器械（代码：FBK）

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。

K260262注射针Mirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE 注射系统Carbon Medical Technologies, Inc.K252021一次性内镜注射针Changzhou New Med Micro-Medtech Co., Ltd.K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675内窥镜注射针Promisemed Hangzhou Meditech Co., Ltd.K241523injeTAK可调尖针（DIS199；DIS201）Laborie Medical Technologies, Corp.

官方来源

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