Owl 653-447
Owl 653-447 is a Class II device made by Diros Technology, Inc., cleared under FDA 510(k) K093185 on 22 Jan 2010 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00825114000421), 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 | Number00825114000421 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093185 | Date22 Jan 2010 | StatusActive |
Official records
- AccessGUDID record 00825114000421
- FDA 510(k) database K093185
Across registries
- FDA 510(k) K093185 decided 22 Jan 2010 Active
- FDA GUDID UDI-DI 00825114000421 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K093185
- Listed FDA GUDID 00825114000421
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Owl
- Generic name
- Percutaneous radio-frequency ablation system generator
- Model / Ref / Catalog
- 653-447
- Primary DI / UDI-DI
- 00825114000421
- 510(k) Number
- FDA product code
- GXD
- GMDN term
- Percutaneous radio-frequency ablation system generator
- Device class
- Class II
- Regulation number
- 882.4400
- GUDID distribution status
- In Commercial Distribution
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