REPLACE-A-TIP ADJUSTABLE HIGH TEMP.— 510(k) K841509

Substantially Equivalent

Suncoast Medical Manufacturers, Inc.

FDA 510(k) clearance K841509 for REPLACE-A-TIP ADJUSTABLE HIGH TEMP., Substantially Equivalent on 1984-12-07. Applicant: Suncoast Medical Manufacturers, Inc..

Clearance details

Applicant: Suncoast Medical Manufacturers, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1984-04-11
Decision date: 1984-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.