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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 / March 2026 / K260013

510(k) cleared

CVAC Image Processor

Calyxo, Inc. · Mar 6, 2026 · K260013

FDA cleared the CVAC Image Processor from Calyxo, Inc. on Mar 6, 2026 under K260013, a traditional 510(k). The device falls under product code FGB, Ureteroscope 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 Jan 5, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Calyxo, Inc. has one other decision in the tracker over the last 12 months: K260965 (CVAC Aspiration System).

Questions & Answers

What did FDA clear under K260013?

K260013 is the FDA 510(k) for CVAC Image Processor, submitted by Calyxo, Inc.. FDA's decision date was Mar 6, 2026, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the CVAC Image Processor?

Calyxo, Inc., based in Pleasanton, CA, is the applicant of record for K260013.

How long did the K260013 review take?

FDA received the submission on Jan 5, 2026 and issued its decision on Mar 6, 2026, 60 days later.

← All decisions in March 2026

Sources