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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 / K260965

510(k) cleared

CVAC Aspiration System

Calyxo, Inc. · Apr 13, 2026 · K260965

FDA cleared the CVAC Aspiration System from Calyxo, Inc. on Apr 13, 2026 under K260965, a special 510(k). The device falls under product code FED, Endoscopic Access Overtube, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 23, 2026. The decision came 21 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: K260013 (CVAC Image Processor).

Questions & Answers

What did FDA clear under K260965?

K260965 is the FDA 510(k) for CVAC Aspiration System, submitted by Calyxo, Inc.. FDA's decision date was Apr 13, 2026, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the CVAC Aspiration System?

Calyxo, Inc., based in Pleasanton, CA, is the applicant of record for K260965.

How long did the K260965 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Apr 13, 2026, 21 days later.

← All decisions in April 2026

Sources