Cleerly Plaque
by Cleerly, Inc
510(k) K261210
Cleerly Plaque is a Class II device made by Cleerly, Inc, cleared under FDA 510(k) K261210 on 29 Jul 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 | NumberK261210 | Date29 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K261210
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- FDA applicant
- Cleerly, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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