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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 / June 2026 / K260790

510(k) cleared

G-Series Grind Guard

ASESSO HEALTH, Inc. · Jun 25, 2026 · K260790

FDA cleared the G-Series Grind Guard from ASESSO HEALTH, Inc. on Jun 25, 2026 under K260790, a traditional 510(k). The device falls under product code OBR, Mouthguard, Over-The-Counter as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Mar 11, 2026. The decision came 106 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 ASESSO HEALTH, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260790?

K260790 is the FDA 510(k) for G-Series Grind Guard, submitted by ASESSO HEALTH, Inc.. FDA's decision date was Jun 25, 2026, under product code OBR (Mouthguard, Over-The-Counter).

Who makes the G-Series Grind Guard?

ASESSO HEALTH, Inc., based in Pleasanton, CA, is the applicant of record for K260790.

How long did the K260790 review take?

FDA received the submission on Mar 11, 2026 and issued its decision on Jun 25, 2026, 106 days later.

← All decisions in June 2026