FLEXIBLE ENDOSCOPIC ELECTRODES— 510(k) K903162

Substantially Equivalent

North American Sterilization & Packaging Co.

FDA 510(k) clearance K903162 for FLEXIBLE ENDOSCOPIC ELECTRODES, Substantially Equivalent on 1990-12-18. Applicant: North American Sterilization & Packaging Co..

Clearance details

Applicant: North American Sterilization & Packaging Co.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1990-07-18
Decision date: 1990-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparta, NJ, US

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Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.