REFLEX ESI— 510(k) K926297

Substantially Equivalent

Richard-Allan Medical Ind., Inc.

FDA 510(k) clearance K926297 for REFLEX ESI, Substantially Equivalent on 1993-10-15. Applicant: Richard-Allan Medical Ind., Inc..

Clearance details

Applicant: Richard-Allan Medical Ind., Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1992-12-14
Decision date: 1993-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, MI, US

Download summary PDF View on FDA.gov ↗

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.