FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
OWL CANNULAE
K Number: K102566
·
Decision Jun 3, 2011
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
65
Applicant Total
8
Review Days
269
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Basic Information
- Device Name
- OWL CANNULAE
- K Number
- K102566
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diros Technology, Inc.
- Date Received
- September 7, 2010
- Decision Date
- June 3, 2011
- Product Code
- GXI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | FDA class 2 | Neurology |
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Other Clearances by Diros Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170708 | OWL RF INSULATED CANNULAE | Jun 27, 2017 | Substantially Equivalent |
| K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | Jul 30, 2015 | Substantially Equivalent |
| K141586 | OWL CANNULAE | Dec 30, 2014 | Substantially Equivalent |
| K110593 | OWL RF PROBES | May 5, 2011 | Substantially Equivalent |
| K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | Jan 22, 2010 | Substantially Equivalent |
| K062758 | OWL URF-3AP | Sep 27, 2006 | Substantially Equivalent |
| K021869 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP | Jul 1, 2002 | Substantially Equivalent |