StatSeal Disc— 510(k) K254073
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K254073 for StatSeal Disc, Substantially Equivalent on 2026-05-13. Applicant: Merit Medical Systems, Inc.. Device class: Unclassified.
Summary
Merit Medical Systems' StatSeal Disc is filed under FRO, drug wound dressings.
Class U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).
Merit filed from South Jordan, Utah. The decision came 146 calendar days after receipt (December 18, 2025 to May 13, 2026).
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Recent devices under product code FRO
view allMore clearances from Merit Medical Systems, Inc.
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . 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.