FDA 510(k)

超声探头 UM-S20-17S（UM-S20-17S）；超声探头 UM-S20-20R（UM-S20-20R）

K号: K250762 · 2025-07-11

决定日期2025-07-11

产品代码ITX

咨询委员会RA

决定实质等同

器械摘要

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) 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 2025-07-11 under 510(k) number K250762. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)?

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K250762.

When did ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) receive FDA 510(k) clearance?

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250762.

Who is the listed applicant for ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)?

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 ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)?

The FDA product code for ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) is ITX.

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-2T1500 K260856一次性远端附件 D-201-13404 K260401EVIS 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-LB K252050一次性活检镊 FB-211D, FB-221D, FB-231D, FB-241D

查看所有 36 个设备 →

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。