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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 / July 2026 / DEN250034

510(k) cleared

Claria System

Claria Medical, Inc. · Jul 2, 2026 · DEN250034 · In the directory

FDA cleared the Claria System from Claria Medical, Inc. on Jul 2, 2026 under DEN250034, a direct 510(k). The device falls under product code SIM, Gynecologic Power Morcellator And Containment System, regulated at 21 CFR 884.4075 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Aug 7, 2025. The decision came 329 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 Claria Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250034?

DEN250034 is the FDA 510(k) for Claria System, submitted by Claria Medical, Inc.. FDA's decision date was Jul 2, 2026, under product code SIM (Gynecologic Power Morcellator And Containment System).

Who makes the Claria System?

Claria Medical, Inc., based in Mountain View, CA, is the applicant of record for DEN250034. The company is listed in the MedDevice Startups directory.

How long did the DEN250034 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Jul 2, 2026, 329 days later.

← All decisions in July 2026

Sources

In the startup directory

Claria Medical

Women's Health · Mountain View, CA