GelPOINT V-Path Vaginal Access System

Culdoscope (and Accessories)

Applied Medical Resources Corporation

The following data is part of a premarket notification filed by Applied Medical Resources Corporation with the FDA for Gelpoint V-path Vaginal Access System.

Pre-market Notification Details

Device IDK220969
510k NumberK220969
Device Name:GelPOINT V-Path Vaginal Access System
ClassificationCuldoscope (and Accessories)
Applicant Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactDavid Yu
CorrespondentDavid Yu
Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeHEW  
CFR Regulation Number884.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-09-16

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