# K051594: Mccartney Access Tube

- Pathway: 510(k) (Traditional)
- Applicant: Gynetech Pty., Ltd.
- Decided: Sep 2, 2005 after 78 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: 1 generation back to K954311 (1996). 1 ancestor in all.
3 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)
- K954311: Koh Colpotomizer System, CooperSurgical, Inc. (1996) Summary page 1.

## Most influential descendants
- K143308: GelPOINT Transvaginal Access Platform (2015), 2 descendants of its own
- 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 McCartney Access Tube is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and as a template for dissection, while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopically assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

Source page: https://510kreport.com/device/K051594
Methodology: https://510kreport.com/methodology