ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),— 510(k) K001161

Substantially Equivalent

Conmedcorp

FDA 510(k) clearance K001161 for ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),, Substantially Equivalent on 2000-06-07. Applicant: Conmedcorp.

Clearance details

Applicant: Conmedcorp
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2000-04-10
Decision date: 2000-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, 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.