StatSeal Disc— 510(k) K254073

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K254073 for StatSeal Disc, Substantially Equivalent on 2026-05-13. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2025-12-18
Decision date: 2026-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.