XENON LIGHT SOURCE— 510(k) K951971

Name: FDA 510(k) clearance K951971
Creator: U.S. Food and Drug Administration
Published: 1995-05-24

Substantially Equivalent

Envision Medical Corp.

FDA 510(k) clearance K951971 for XENON LIGHT SOURCE, Substantially Equivalent on 1995-05-24. Applicant: Envision Medical Corp.. Device class: 2.

Clearance details

Applicant: Envision Medical Corp.
Product code: Code GCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-27
Decision date: 1995-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

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.