Epimed 296-DPIA06B
Epimed 296-DPIA06B is a Class II device made by Minta Medical Limited, cleared under FDA 510(k) K090608 on 14 Jun 2010 and listed in FDA GUDID since 30 Oct 2017 (UDI-DI 05060224334560), 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 | Number05060224334560 | Date30 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090608 | Date14 Jun 2010 | StatusActive |
Official records
- AccessGUDID record 05060224334560
- FDA 510(k) database K090608
Across registries
- FDA 510(k) K090608 decided 14 Jun 2010 Active
- FDA GUDID UDI-DI 05060224334560 listed 30 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K090608
- Listed FDA GUDID 05060224334560
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Epimed
- Generic name
- Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
- Model / Ref / Catalog
- 296-DPIA06B
- Primary DI / UDI-DI
- 05060224334560
- 510(k) Number
- FDA product code
- GXI
- GMDN term
- Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
- Device class
- Class II
- Regulation number
- 882.4725
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
- MRI safety
- MR Unsafe
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