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The Tracker / August 2026 / K260972

510(k) cleared

OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor

Sony Corporation · Aug 26, 2026 · K260972

FDA cleared the OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor from Sony Corporation on Aug 26, 2026 under K260972, 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 Mar 24, 2026. The decision came 155 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 Sony Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260972?

K260972 is the FDA 510(k) for OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor, submitted by Sony Corporation. FDA's decision date was Aug 26, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor?

Sony Corporation, based in Yokohama-Shi, is the applicant of record for K260972.

How long did the K260972 review take?

FDA received the submission on Mar 24, 2026 and issued its decision on Aug 26, 2026, 155 days later.

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