LED LCD Monitor (OEV-271H)— 510(k) K261614

Substantially Equivalent

Lg Electronics.Inc

FDA 510(k) clearance K261614 for LED LCD Monitor (OEV-271H), Substantially Equivalent on 2026-07-17. Applicant: Lg Electronics.Inc. Device class: 2.

Summary

LG Electronics' LED LCD Monitor (OEV-271H) is filed under GCJ, laparoscopes for general and plastic surgery. The device name describes a monitor, which the code name doesn't mention, and the record doesn't explain the fit.

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.

LG Electronics filed from Gumi-si, South Korea. Review took 63 calendar days (May 15 to July 17, 2026).

Clearance details

Applicant
Lg Electronics.Inc
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
Gumi-Si, KR
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.