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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 / October 2025 / K251162

510(k) cleared

CUSA® Clarity Ultrasonic Surgical Aspirator System

Integra LifeSciences Corporation · Oct 8, 2025 · K251162

FDA cleared the CUSA® Clarity Ultrasonic Surgical Aspirator System from Integra LifeSciences Corporation on Oct 8, 2025 under K251162, a traditional 510(k). The device falls under product code LFL, Instrument, Ultrasonic Surgical as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 15, 2025. The decision came 176 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Integra LifeSciences Corporation has one other decision in the tracker over the last 12 months: K261004 (Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)).

Questions & Answers

What did FDA clear under K251162?

K251162 is the FDA 510(k) for CUSA® Clarity Ultrasonic Surgical Aspirator System, submitted by Integra LifeSciences Corporation. FDA's decision date was Oct 8, 2025, under product code LFL (Instrument, Ultrasonic Surgical).

Who makes the CUSA® Clarity Ultrasonic Surgical Aspirator System?

Integra LifeSciences Corporation, based in Princeton, NJ, is the applicant of record for K251162.

How long did the K251162 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Oct 8, 2025, 176 days later.

← All decisions in October 2025

Sources