INTEGRA LICOX PTO2 MONITOR— 510(k) K131184

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K131184 for INTEGRA LICOX PTO2 MONITOR, Substantially Equivalent on 2013-08-30. Applicant: Integra Lifesciences Corp..

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code GWM
Advisory panel: Neurology
Date received: 2013-04-25
Decision date: 2013-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.