SINGLE USE LAPARSCOPIC ELECTRODE— 510(k) K904240

Substantially Equivalent

Aspen Labs

FDA 510(k) clearance K904240 for SINGLE USE LAPARSCOPIC ELECTRODE, Substantially Equivalent on 1991-02-19. Applicant: Aspen Labs.

Clearance details

Applicant: Aspen Labs
Product code: Code HFG
Advisory panel: Obstetrics/Gynecology
Date received: 1990-09-13
Decision date: 1991-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

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Adverse events under product code HFG

product code HFG

Death: 3
Injury: 121
Total: 124

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.