Owl 463-013-S
Owl 463-013-S is a Class II device made by Diros Technology, Inc., cleared under FDA 510(k) K010202 on 31 Oct 2001 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00825114000834), 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 | Number00825114000834 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK010202 | Date31 Oct 2001 | StatusActive |
Official records
- AccessGUDID record 00825114000834
- FDA 510(k) database K010202
Across registries
- FDA 510(k) K010202 decided 31 Oct 2001 Active
- FDA GUDID UDI-DI 00825114000834 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K010202
- Listed FDA GUDID 00825114000834
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Owl
- Generic name
- Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
- Model / Ref / Catalog
- 463-013-S
- Primary DI / UDI-DI
- 00825114000834
- 510(k) Number
- FDA product code
- GXI
- GMDN term
- Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
- Device class
- Class II
- Regulation number
- 882.4725
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization