510(k) K070376— CONMED LINVATEC 300W XENON LIGHT SOURCE

Substantially Equivalent

Conmed Linvatec

Clearance details

Applicant: Conmed Linvatec
Product code: Code GCT
Advisory panel: Gastroenterology, Urology
Date received: 2007-02-08
Decision date: 2007-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

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.