K254073
- 510(k) number
- K254073
- Device name
- StatSeal Disc
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2026-05-13
- Date received
- 2025-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K254073.pdf
Official FDA record: K254073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.