K122278

Substantially Equivalent

BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR

Applicant: Baylis Medical Company, Inc.
Product code: GEI
Advisory panel: General, Plastic Surgery
Date received: 2012-07-30
Decision date: 2012-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.