CodMan Certas Plus Programmable Valve— 510(k) K182265

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K182265 for CodMan Certas Plus Programmable Valve, Substantially Equivalent on 2018-11-20. Applicant: Integra Lifesciences Corp..

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code JXG
Advisory panel: Neurology
Date received: 2018-08-21
Decision date: 2018-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.