# K143308: GelPOINT Transvaginal Access Platform

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Oct 13, 2015 after 329 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: 2 generations back to K954311 (1996). 2 ancestors in all.
2 later devices descend 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)
- K051594: Mccartney Access Tube, Gynetech Pty., Ltd. (2005) Summary page 4.

## Most influential descendants
- K191294: Transvaginal Access Platform (2019), 1 descendant of its own
- K243152: GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (2025), 0 descendants of its own

## Indications for use
The GelPOINT Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopic assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

Source page: https://510kreport.com/device/K143308
Methodology: https://510kreport.com/methodology