COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH— 510(k) K032223

Substantially Equivalent

Cook Vascular, Inc.

FDA 510(k) clearance K032223 for COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH, Substantially Equivalent on 2003-10-15. Applicant: Cook Vascular, Inc..

Clearance details

Applicant: Cook Vascular, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2003-07-21
Decision date: 2003-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leechburg, PA, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.