# K220969: GelPOINT V-Path Vaginal Access System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corporation
- Decided: Sep 16, 2022 after 165 days
- Product code: MOK (Vaginoscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950639 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950639: Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 4.

## Indications for 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.

Source page: https://510kreport.com/device/K220969
Methodology: https://510kreport.com/methodology