INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER— 510(k) K121159

Substantially Equivalent

Integra Lifescience Corportation

FDA 510(k) clearance K121159 for INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER, Substantially Equivalent on 2012-07-20. Applicant: Integra Lifescience Corportation.

Clearance details

Applicant: Integra Lifescience Corportation
Product code: Code GWM
Advisory panel: Neurology
Date received: 2012-04-16
Decision date: 2012-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

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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.