CuratOR EX2742— 510(k) K262397

Substantially Equivalent

Eizo Corporation

FDA 510(k) clearance K262397 for CuratOR EX2742, Substantially Equivalent on 2026-09-11. Applicant: Eizo Corporation. Device class: 2.

Summary

The CuratOR EX2742 is from EIZO's CuratOR line of surgical displays, the monitors that show endoscopic and other imaging in the operating room. It's filed under GCJ, laparoscopes for general and plastic surgery, where video components for laparoscopy are cleared.

Class II, 21 CFR 876.1500. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).

EIZO filed from Hakusan, Ishikawa, Japan. Review took 59 days (July 14 to September 11, 2026). Displays in this code mostly come down to image quality and electrical safety testing, and they tend to clear quickly.

Clearance details

Applicant
Eizo Corporation
Product code
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
Hakusan, Ishikawa, JP
Download summary PDFView on FDA.gov ↗

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Adverse 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.