BOWEN CANNULA— 510(k) K863150

Substantially Equivalent

Bowen & Company, Inc.

FDA 510(k) clearance K863150 for BOWEN CANNULA, Substantially Equivalent on 1986-09-05. Applicant: Bowen & Company, Inc..

Clearance details

Applicant: Bowen & Company, Inc.
Product code: Code GEA
Advisory panel: General, Plastic Surgery
Date received: 1986-08-15
Decision date: 1986-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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Adverse events under product code GEA

product code GEA

Malfunction: 587
Total: 587

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.