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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 a medical device manufactured by Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2022-09-16 under approval 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. It is manufactured by Applied Medical Resources Corporation. The 510(k) number is K220969.

When was GelPOINT V-Path Vaginal Access System approved by the FDA?

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

What company makes GelPOINT V-Path Vaginal Access System?

GelPOINT V-Path Vaginal Access System is manufactured by Applied Medical Resources Corporation.

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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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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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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