OsteoCool™ RF Ablation System OC01-R
by Medtronic Sofamor Danek, Inc.
OsteoCool™ RF Ablation System OC01-R is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K152057 on 24 Nov 2015 and listed in FDA GUDID since 29 Jul 2017 (UDI-DI 00643169641211), 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 | GUDID listing | Number00643169641211 | Date29 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152057 | Date24 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00643169641211
- FDA 510(k) database K152057
Across registries
- FDA 510(k) K152057 decided 24 Nov 2015 Active
- FDA GUDID UDI-DI 00643169641211 listed 29 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K152057
- Listed FDA GUDID 00643169641211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OsteoCool™ RF Ablation System
- Generic name
- Percutaneous radio-frequency ablation system generator
- Model / reference
- OC01-R
- Primary DI / UDI-DI
- 00643169641211
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Percutaneous radio-frequency ablation system generator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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