ENT MR8 1847B25SDF
by Medtronic Powered Surgical Solutions 2 variants
ENT MR8 1847B25SDF is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K183515 on 12 May 2019 and listed in FDA GUDID since 2 Oct 2020 (UDI-DI 00763000356224), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00763000356224 | Date2 Oct 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183515 | Date12 May 2019 | StatusActive |
Official records
- AccessGUDID record 00763000356224
- FDA 510(k) database K183515
Across registries
- FDA 510(k) K183515 decided 12 May 2019 Active
- FDA GUDID UDI-DI 00763000356224 listed 2 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K183515
- Listed FDA GUDID 00763000356224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ENT MR8
- Generic name
- Orthopaedic bur, single-use
- Model / reference
- 1847B25SDF
- Primary DI / UDI-DI
- 00763000356224
- 510(k) Number
- FDA product code
- ERL
- GMDN term
- Orthopaedic bur, single-use
- Device class
- Class II
- Regulation number
- 874.4250
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic bur, single-use.