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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 / K261614

510(k) cleared

LED LCD Monitor (OEV-271H)

Lg Electronics.Inc · Jul 17, 2026 · K261614

FDA cleared the LED LCD Monitor (OEV-271H) from Lg Electronics.Inc on Jul 17, 2026 under K261614, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 15, 2026. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

Lg Electronics.Inc has one other decision in the tracker over the last 12 months: K261213 (Medical Monitor (40HT513D)).

Questions & Answers

What did FDA clear under K261614?

K261614 is the FDA 510(k) for LED LCD Monitor (OEV-271H), submitted by Lg Electronics.Inc. FDA's decision date was Jul 17, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the LED LCD Monitor (OEV-271H)?

Lg Electronics.Inc, based in Gumi-Si, is the applicant of record for K261614.

How long did the K261614 review take?

FDA received the submission on May 15, 2026 and issued its decision on Jul 17, 2026, 63 days later.

← All decisions in July 2026

Sources