VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS— 510(k) K042604

Name: FDA 510(k) clearance K042604
Creator: U.S. Food and Drug Administration
Published: 2004-10-22

Substantially Equivalent

Valley Forge Scientific Corp.

FDA 510(k) clearance K042604 for VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS, Substantially Equivalent on 2004-10-22. Applicant: Valley Forge Scientific Corp.. Device class: 2.

Clearance details

Applicant: Valley Forge Scientific Corp.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2004-09-24
Decision date: 2004-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Oaks, PA, US

Download summary PDF View on FDA.gov ↗

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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.