ELPHA 500— 510(k) K823581

Substantially Equivalent

Prothia USA, Inc.

FDA 510(k) clearance K823581 for ELPHA 500, Substantially Equivalent on 1983-03-24. Applicant: Prothia USA, Inc..

Clearance details

Applicant: Prothia USA, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1982-12-06
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.