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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 / DEN250068

510(k) cleared

OTTAVA Robotic Surgical System

Auris Health, Inc., part of Johnson & Johnson MedTech · Jul 21, 2026 · DEN250068

FDA cleared the OTTAVA Robotic Surgical System from Auris Health, Inc., part of Johnson & Johnson MedTech on Jul 21, 2026 under DEN250068, a direct 510(k). The device falls under product code SIR, Integrated Operating Table-Electromechanical Surgical System, regulated at 21 CFR 878.4966 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 18, 2025. The decision came 215 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Auris Health, Inc., part of Johnson & Johnson MedTech has one other decision in the tracker over the last 12 months: K260382 (MONARCH Platform (MON-000008)).

Questions & Answers

What did FDA clear under DEN250068?

DEN250068 is the FDA 510(k) for OTTAVA Robotic Surgical System, submitted by Auris Health, Inc., part of Johnson & Johnson MedTech. FDA's decision date was Jul 21, 2026, under product code SIR (Integrated Operating Table-Electromechanical Surgical System).

Who makes the OTTAVA Robotic Surgical System?

Auris Health, Inc., part of Johnson & Johnson MedTech, based in Santa Clara, CA, is the applicant of record for DEN250068.

How long did the DEN250068 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Jul 21, 2026, 215 days later.

← All decisions in July 2026

Sources