K945585

Substantially Equivalent

COMAN(R) CU-11 MODEL NUMBER 82-6634

Applicant: Johnson & Johnson Professionals, Inc.
Product code: GWM
Advisory panel: Neurology
Date received: 1994-11-14
Decision date: 1995-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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.