CuratOR EX2742— 510(k) K262397
Substantially EquivalentEizo 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 from EIZO is filed under GCJ, laparoscopes for general and plastic surgery. The record doesn't describe the device.
Class II, 21 CFR 876.1500, filed as a Traditional 510(k). The record lists Gastroenterology and Urology as the advisory panel and General and Plastic Surgery as the review panel.
EIZO filed from Hakusan, Ishikawa, Japan. Review took 59 days (July 14 to September 11, 2026).
Clearance details
- Applicant
- Eizo 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
- Hakusan, Ishikawa, JP
Recent devices under product code GCJ
view allMore clearances from Eizo Corporation
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.