# K243152: GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Oct 2, 2025 after 367 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: 4 generations back to K954311 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191294: Transvaginal Access Platform, Applied Medical Resources Corp. (2019) Summary page 6.

## Indications for use
The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and maintain insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device may be used for sentinel pelvic lymph node dissection occurring in the retroperitoneal space. The device is also a conduit for the extraction of specimens.

Source page: https://510kreport.com/device/K243152
Methodology: https://510kreport.com/methodology