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

Clearance details

Applicant

Cook Vascular, Inc.

Product code

Product code GEI

Device class

Class 2

Regulation

21 CFR 878.4400

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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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 →