WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K251041

510(k) cleared

GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100

Actuated Medical, Inc. · Oct 31, 2025 · K251041

FDA cleared the GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 from Actuated Medical, Inc. on Oct 31, 2025 under K251041, a traditional 510(k). The device falls under product code FDS, Gastroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 3, 2025. The decision came 211 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Actuated Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251041?

K251041 is the FDA 510(k) for GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100, submitted by Actuated Medical, Inc.. FDA's decision date was Oct 31, 2025, under product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Who makes the GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100?

Actuated Medical, Inc., based in Bellefonte, PA, is the applicant of record for K251041.

How long did the K251041 review take?

FDA received the submission on Apr 3, 2025 and issued its decision on Oct 31, 2025, 211 days later.

← All decisions in October 2025