LEVEEN SUPERSLIM NEEDLE ELECTRODE— 510(k) K113090

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K113090 for LEVEEN SUPERSLIM NEEDLE ELECTRODE, Substantially Equivalent on 2012-03-15. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2011-10-19
Decision date: 2012-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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.