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FDA 510(k)

GelPOINT V-Path Vaginal Access System

K-Number: K220969 · 2022-09-16

ApplicantApplied Medical Resources Corporation
Decision Date2022-09-16
Product CodeMOK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Applied Medical Resources Corporation as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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