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510(k) Data Aggregation
K Number
K220969Device Name
GelPOINT V-Path Vaginal Access System
Manufacturer
Applied Medical Resources Corporation
Date Cleared
2022-09-16
(165 days)
Product Code
MOK, VAG
Regulation Number
884.1630Why did this record match?
Product Code :
MOK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.
Device Description
The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.
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