# K231254: GripTract-GI Endoscopic Tissue Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: Actuated Medical, Inc.
- Decided: Nov 3, 2023 after 186 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K103510: Unimax Specimen Retrieval System, Unimax Medical Systems, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K242325: GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (2024), 1 descendant of its own
- K251041: GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (2025), 0 descendants of its own

## Indications for use
The GripTract-GI Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 —12.0 mm and working length of 168 — 170 cm.

Source page: https://510kreport.com/device/K231254
Methodology: https://510kreport.com/methodology