FDA 510(k)

GelPOINT V-Path Vaginal Access System

K号: K220969 · 2022-09-16

申请人Applied Medical Resources Corporation

决定日期2022-09-16

产品代码MOK

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器械摘要

GelPOINT V-Path Vaginal Access System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K220969. The device is classified under product code MOK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GelPOINT V-Path Vaginal Access System?

GelPOINT V-Path Vaginal Access System is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K220969.

When did GelPOINT V-Path Vaginal Access System receive FDA 510(k) clearance?

GelPOINT V-Path Vaginal Access System received FDA 510(k) clearance on 2022-09-16, under 510(k) number K220969.

Who is the listed applicant for GelPOINT V-Path Vaginal Access System?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GelPOINT V-Path Vaginal Access System?

The FDA product code for GelPOINT V-Path Vaginal Access System is MOK.

列明Applied Medical Resources Corporation为申报人的其他记录

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器械摘要

常见问题

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列明Applied Medical Resources Corporation为申报人的其他记录

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