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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 / April 2026 / DEN250023

510(k) cleared

Aurie System

Cathbuddy, Inc. · Apr 30, 2026 · DEN250023

FDA cleared the Aurie System from Cathbuddy, Inc. on Apr 30, 2026 under DEN250023, a direct 510(k). The device falls under product code SHV, Reusable Intermittent Urinary Catheter System, regulated at 21 CFR 876.5120 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 6, 2025. The decision came 328 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 Cathbuddy, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250023?

DEN250023 is the FDA 510(k) for Aurie System, submitted by Cathbuddy, Inc.. FDA's decision date was Apr 30, 2026, under product code SHV (Reusable Intermittent Urinary Catheter System).

Who makes the Aurie System?

Cathbuddy, Inc., based in Syracuse, NY, is the applicant of record for DEN250023.

How long did the DEN250023 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Apr 30, 2026, 328 days later.

← All decisions in April 2026