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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 / K261610

510(k) cleared

Verge Microcatheter

Instylla, Inc. · Jun 11, 2026 · K261610

FDA cleared the Verge Microcatheter from Instylla, Inc. on Jun 11, 2026 under K261610, a special 510(k). The device falls under product code KRA, Catheter, Continuous Flush, regulated at 21 CFR 870.1210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 14, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Instylla, Inc. has 2 other decisions in the tracker over the last 12 months: K253769 (Instylla Delivery Kit), K253677 (Tembo Embolic System).

Questions & Answers

What did FDA clear under K261610?

K261610 is the FDA 510(k) for Verge Microcatheter, submitted by Instylla, Inc.. FDA's decision date was Jun 11, 2026, under product code KRA (Catheter, Continuous Flush).

Who makes the Verge Microcatheter?

Instylla, Inc., based in Bedford, MA, is the applicant of record for K261610.

How long did the K261610 review take?

FDA received the submission on May 14, 2026 and issued its decision on Jun 11, 2026, 28 days later.

← All decisions in June 2026

Sources