OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor— 510(k) K260972
Substantially EquivalentSony Corporation
FDA 510(k) clearance K260972 for OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor, Substantially Equivalent on 2026-08-26. Applicant: Sony Corporation. Device class: 2.
Summary
Sony's submission lists three LCD monitors: OEV-271MUH, OEV-321MUH, and OEV-431MUH. They're filed under product code GCJ (Laparoscope, General & Plastic Surgery).
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Sony filed from Yokohama-Shi, Japan. The substantially equivalent decision came 155 calendar days after receipt (March 24 to August 26, 2026).
Clearance details
- Device name as filed
- OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
- Applicant
- Sony Corporation
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yokohama-Shi, JP
Recent devices under product code GCJ
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.