MUC-X— 510(k) K893204

Substantially Equivalent

Island Medical

FDA 510(k) clearance K893204 for MUC-X, Substantially Equivalent on 1989-06-01. Applicant: Island Medical.

Clearance details

Applicant: Island Medical
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1989-04-26
Decision date: 1989-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fernandina Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.