# K191294: Transvaginal Access Platform

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Sep 6, 2019 after 115 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954311 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143308: GelPOINT Transvaginal Access Platform, Applied Medical Resources (2015) Summary page 4.

## Most influential descendants
- K243152: GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (2025), 0 descendants of its own

## Indications for use
The Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.

Source page: https://510kreport.com/device/K191294
Methodology: https://510kreport.com/methodology