510(k) K872214— COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS

Substantially Equivalent

CooperVision, Inc.

Clearance details

Applicant: CooperVision, Inc.
Product code: Code GEA
Advisory panel: General, Plastic Surgery
Date received: 1987-06-09
Decision date: 1987-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.