ACTI-ICP MONITORING SYSTEM— 510(k) K003905

Substantially Equivalent

Innerspace, Inc.

FDA 510(k) clearance K003905 for ACTI-ICP MONITORING SYSTEM, Substantially Equivalent on 2001-06-15. Applicant: Innerspace, Inc..

Clearance details

Applicant: Innerspace, Inc.
Product code: Code GWM
Advisory panel: Neurology
Date received: 2000-12-19
Decision date: 2001-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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.