AcuPebble Ox (200)
510(k) K243092
AcuPebble Ox (200) is a Class II device made by Acurable Limited, cleared under FDA 510(k) K243092 on 19 Mar 2025, 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 | NumberK243092 | Date19 Mar 2025 | StatusActive |
Official records
- FDA 510(k) database K243092
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNR
- Device class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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