# K110792: Gelpoint Path

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: May 23, 2011 after 63 days
- Product code: FER (Anoscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K940232 (1994). 27 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103253: Sils Port, Coviden (Formerly Registered AS US Surgical, A Div (2011) Summary page 1.

## Most influential descendants
- K133393: Gelpoint Path Transanal Access Platform (2014), 1 descendant of its own
- K171701: GelPOINT Path Transanal Access Platform (2017), 0 descendants of its own
- K120898: Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar 8850XX Sealing CA (2012), 0 descendants of its own

## Indications for use
The GelPOINT Path is indicated for multiple instrument or camera access through the anus for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision, and fistula repair.

Source page: https://510kreport.com/device/K110792
Methodology: https://510kreport.com/methodology