Owl D467-010-Tch
Owl D467-010-Tch is a Class II device made by Diros Technology, Inc., cleared under FDA 510(k) K110593 on 5 May 2011 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00825114006270), 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 | Number00825114006270 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110593 | Date5 May 2011 | StatusActive |
Official records
- AccessGUDID record 00825114006270
- FDA 510(k) database K110593
Across registries
- FDA 510(k) K110593 decided 5 May 2011 Active
- FDA GUDID UDI-DI 00825114006270 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K110593
- Listed FDA GUDID 00825114006270
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- Withdrawn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, single-use
- Model / Ref / Catalog
- D467-010-TCH
- Primary DI / UDI-DI
- 00825114006270
- 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
- MRI safety
- MR Unsafe
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