LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE— 510(k) K912637

Substantially Equivalent

Dexide, Inc.

FDA 510(k) clearance K912637 for LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE, Substantially Equivalent on 1991-10-04. Applicant: Dexide, Inc..

Clearance details

Applicant: Dexide, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1991-06-14
Decision date: 1991-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, 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.