FDA 510(k)

GelPOINT V-Path 阴道アクセスシステム

K番号: K220969 · 2022-09-16

申請者Applied Medical Resources Corporation

決定日2022-09-16

製品コードMOK

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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医療機器の概要

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