FDA 510(k)

Senhance超声波系统

K号: K182421 · 2019-01-11

决定日期2019-01-11

产品代码NAY

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决定实质等同

器械摘要

Senhance Ultrasonic System is the device name listed in this FDA 510(k) record. The listed applicant is Transenterix, Inc.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K182421. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Senhance Ultrasonic System?

Senhance Ultrasonic System is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Transenterix, Inc.. The 510(k) number is K182421.

When did Senhance Ultrasonic System receive FDA 510(k) clearance?

Senhance Ultrasonic System received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182421.

Who is the listed applicant for Senhance Ultrasonic System?

The FDA 510(k) record lists Transenterix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Senhance Ultrasonic System?

The FDA product code for Senhance Ultrasonic System is NAY.

列明Transenterix, Inc.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。

K202166Senhance手术系统 K200049Senhance手术系统 K192877Senhance手术系统 K191482Senhance手术系统 K183098Senhance手术系统 K181517Senhance手术系统

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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。