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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 / February 2026 / P250023

PMA approved

Allurion Gastric Balloon System

Allurion Technologies, Inc. · Feb 20, 2026 · P250023 · In the directory

FDA approved the Allurion Gastric Balloon System from Allurion Technologies, Inc. on Feb 20, 2026 under P250023, an original premarket approval. The device falls under product code LTI, Implant, Intragastric For Morbid Obesity as a Class 3 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 30, 2025. The decision came 235 days later.

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

Questions & Answers

What did FDA approve under P250023?

P250023 is the FDA PMA for Allurion Gastric Balloon System, submitted by Allurion Technologies, Inc.. FDA's decision date was Feb 20, 2026, under product code LTI (Implant, Intragastric For Morbid Obesity).

Who makes the Allurion Gastric Balloon System?

Allurion Technologies, Inc., based in Natick, MA, is the applicant of record for P250023. The company is listed in the MedDevice Startups directory.

How long did the P250023 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Feb 20, 2026, 235 days later.

← All decisions in February 2026