LINVATEC 300W XENON LIGHT SOURCE— 510(k) K031994

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K031994 for LINVATEC 300W XENON LIGHT SOURCE, Substantially Equivalent on 2003-08-21. Applicant: Linvatec Corp..

Clearance details

Applicant: Linvatec Corp.
Product code: Code GCT
Advisory panel: Gastroenterology, Urology
Date received: 2003-06-27
Decision date: 2003-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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.