# K171701: GelPOINT Path Transanal Access Platform

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Jul 20, 2017 after 42 days
- Product code: FER (Anoscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K940232 (1994). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133393: Gelpoint Path Transanal Access Platform, Applied Medical Resources Corp. (2014) Summary page 4.
- K110792: Gelpoint Path, Applied Medical Resources Corp. (2011) Summary page 4.

## Recalls of this device
- Dec 12, 2018 · Class II · Z-0510-2020: Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

## Indications for use
The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

Source page: https://510kreport.com/device/K171701
Methodology: https://510kreport.com/methodology