WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / January 2026 / K253842

510(k) cleared

Vena MicroAngioscope System

Vena Medical Holdings Corp · Jan 28, 2026 · K253842 · In the directory

FDA cleared the Vena MicroAngioscope System from Vena Medical Holdings Corp on Jan 28, 2026 under K253842, a traditional 510(k). The device falls under product code LYK, Angioscope, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 2, 2025. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Vena Medical Holdings Corp has one other decision in the tracker over the last 12 months: K251767 (Vena MicroAngioscope System).

Questions & Answers

What did FDA clear under K253842?

K253842 is the FDA 510(k) for Vena MicroAngioscope System, submitted by Vena Medical Holdings Corp. FDA's decision date was Jan 28, 2026, under product code LYK (Angioscope).

Who makes the Vena MicroAngioscope System?

Vena Medical Holdings Corp, based in Kitchener, is the applicant of record for K253842. The company is listed in the MedDevice Startups directory.

How long did the K253842 review take?

FDA received the submission on Dec 2, 2025 and issued its decision on Jan 28, 2026, 57 days later.

← All decisions in January 2026

Sources

In the startup directory

Vena Medical

Imaging & Radiology · Kitchener, ON, Canada