BIPOLAR PENCIL, MODEL 3901-002, 3900-002— 510(k) K010487

Substantially Equivalent

Medtronic PS Medical

FDA 510(k) clearance K010487 for BIPOLAR PENCIL, MODEL 3901-002, 3900-002, Substantially Equivalent on 2001-05-03. Applicant: Medtronic PS Medical.

Clearance details

Applicant: Medtronic PS Medical
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2001-02-20
Decision date: 2001-05-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Goleta, CA, 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.