NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT— 510(k) K051599

Substantially Equivalent

Neurorecovery, Inc.

FDA 510(k) clearance K051599 for NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT, Substantially Equivalent on 2005-07-19. Applicant: Neurorecovery, Inc..

Clearance details

Applicant: Neurorecovery, Inc.
Product code: Code GWM
Advisory panel: Neurology
Date received: 2005-06-16
Decision date: 2005-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, 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.