# K251041: GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100

- Pathway: 510(k) (Traditional)
- Applicant: Actuated Medical, Inc.
- Decided: Oct 31, 2025 after 211 days
- Product code: FDS (Gastroscope 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: 2 generations back to K231254 (2023). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242325: GripTract-GI Endoscopic Tissue Manipulator Lower GI Models, Actuated Medical, Inc. (2024) Summary page 5.

## Indications for use
The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Upper GI Model 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 Upper GI Model is indicated for use in the upper gastrointestinal tract with any standard endoscope as follows: Endoscope Distal Tip Outer Diameter (mm): 9.8- 10.5 Endoscope Working Length (cm): 103 - 110 GripTract Model#: GT-GS100

Source page: https://510kreport.com/device/K251041
Methodology: https://510kreport.com/methodology