StatSeal Disc
FDA 510(k) K254073 · Merit Medical Systems, Inc.
510(k) numberK254073
Submission
- Device name
- StatSeal Disc
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- December 18, 2025
- Decision date
- May 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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Questions and answers
When was StatSeal Disc cleared by the FDA?
StatSeal Disc (K254073) received a 510(k) decision of Substantially Equivalent on May 13, 2026, 146 days after the submission was received.
What is the product code of K254073?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.