免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

吸水阀（MAJ-1443）；空气/水阀（MAJ-1444）

K号: K250949 · 2025-07-16

申请人Olympus Medical Systems Corporation
决定日期2025-07-16
产品代码ODC
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

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) 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 2025-07-16 under 510(k) number K250949. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K250949.

When did Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) receive FDA 510(k) clearance?

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) received FDA 510(k) clearance on 2025-07-16, under 510(k) number K250949.

Who is the listed applicant for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

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 Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

The FDA product code for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is ODC.

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：ODC）

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。

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca 空气/水及吸阀Boston ScientificK250732一次性内窥镜阀门套装Yangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems CorporationK250140Defendo Fujifilm 700 单次使用清洁适配器Steris Corparation

官方来源

在 FDA 数据库中查看 →

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。

↑