BMC RF CANNULA— 510(k) K972846

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K972846 for BMC RF CANNULA, Substantially Equivalent on 1998-07-17. Applicant: Baylis Medical Co., Inc..

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 1997-08-01
Decision date: 1998-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.