OWL CANNULAE
FDA 510(k) clearance K141586 · decided 2014-12-30
Clearance details
- K-number
- K141586
- Device name
- OWL CANNULAE
- Applicant
- Diros Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-13
- Decision date
- 2014-12-30
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Markham,On, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Diros Technology
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.