ASCENTEC MEDICZAL SYSTEMS LAPAROSCOPIC ELECTRODE— 510(k) K914252

Substantially Equivalent

Ascentec Medical Systems

FDA 510(k) clearance K914252 for ASCENTEC MEDICZAL SYSTEMS LAPAROSCOPIC ELECTRODE, Substantially Equivalent on 1991-12-13. Applicant: Ascentec Medical Systems.

Clearance details

Applicant: Ascentec Medical Systems
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1991-09-23
Decision date: 1991-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.