K861306

Substantially Equivalent

SUCTION SYSTEM

Applicant: Axiom Medical, Inc.
Product code: GEA
Advisory panel: General, Plastic Surgery
Date received: 1986-04-08
Decision date: 1986-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramount, CA, US

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.