FDA 510(k)

uVue HSG/SHG Catheter

K号: K160217 · 2016-10-06

决定日期2016-10-06

产品代码LKF

咨询委员会OB

决定Substantially Equivalent

器械摘要

uVue HSG/SHG Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K160217. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the uVue HSG/SHG Catheter?

uVue HSG/SHG Catheter is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Cook Incorporated. The 510(k) number is K160217.

When did uVue HSG/SHG Catheter receive FDA 510(k) clearance?

uVue HSG/SHG Catheter received FDA 510(k) clearance on 2016-10-06, under 510(k) number K160217.

Who is the listed applicant for uVue HSG/SHG Catheter?

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

What is the FDA product code for uVue HSG/SHG Catheter?

The FDA product code for uVue HSG/SHG Catheter is LKF.

列明Cook Incorporated为申报人的其他记录

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