BC-5— 510(k) K191693

Substantially Equivalent

Reveallux, Corp

FDA 510(k) clearance K191693 for BC-5, Substantially Equivalent on 2019-11-01. Applicant: Reveallux, Corp.

Clearance details

Applicant: Reveallux, Corp
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2019-06-25
Decision date: 2019-11-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Columbus, NE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.