# K242325: GripTract-GI Endoscopic Tissue Manipulator Lower GI Models

- Pathway: 510(k) (Traditional)
- Applicant: Actuated Medical, Inc.
- Decided: Oct 4, 2024 after 59 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
Longest line of descent: 1 generation back to K231254 (2023). 1 ancestor in all.
1 later device descends 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)
- K231254: GripTract-GI Endoscopic Tissue Manipulator, Actuated Medical, Inc. (2023) Summary page 5.

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

## Indications for use
The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) Lower Gl Models are accessories 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 Lower Gl Models are indicated for use in the large intestine with any standard endoscope as follows: Endoscope Endoscope GripTract Distal Tip Outer Diameter (mm) Working Length (cm) Model # 12.8-13.3 168 - 170 GT-CL170 12.8-13.3 130 - 133 GT-CL130 11.5-12.0 168 - 170 GT-CM170 11.5-12.0 130 - 133 GT-CM130

Source page: https://510kreport.com/device/K242325
Methodology: https://510kreport.com/methodology