THE KEYMED HI-LIGHT 250 LIGHT SOURCE— 510(k) K864801

Name: FDA 510(k) clearance K864801
Creator: U.S. Food and Drug Administration
Published: 1986-12-24

Substantially Equivalent

Keymed, Inc.

FDA 510(k) clearance K864801 for THE KEYMED HI-LIGHT 250 LIGHT SOURCE, Substantially Equivalent on 1986-12-24. Applicant: Keymed, Inc.. Device class: 2.

Clearance details

Applicant: Keymed, Inc.
Product code: Code GCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1986-12-09
Decision date: 1986-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Essex Ss2 5qh England, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCT

product code GCT

Malfunction: 1,393
Other: 2
Total: 1,395

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.