510(k) K930900— COOK ASPIRATION UNIT

Substantially Equivalent

Cook Ob/Gyn

Clearance details

Applicant: Cook Ob/Gyn
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 1993-02-22
Decision date: 1993-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.