StatSeal Disc
by Merit Medical Systems, Inc.
510(k) K254073
StatSeal Disc is a device classified as Unclassified made by Merit Medical Systems, Inc., cleared under FDA 510(k) K254073 on 13 May 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK254073 | Date13 May 2026 | StatusActive |
Official records
- FDA 510(k) database K254073
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRO
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
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