FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
K Number: K141456
·
Decision Oct 8, 2014
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
34
Applicant Total
9
Review Days
128
Basic Information
- Device Name
- THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
- K Number
- K141456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FIAGON GMBH
- Date Received
- June 2, 2014
- Decision Date
- October 8, 2014
- Product Code
- PGW
- Advisory Committee
- Neurology
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by FIAGON GMBH
| K Number | Device Name | ||
|---|---|---|---|
| K163209 | Fiagon Navigation System | Sep 14, 2017 | Substantially Equivalent |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | Feb 16, 2017 | Substantially Equivalent |
| K161940 | Guidewire 0.6 Single Use | Sep 18, 2016 | Substantially Equivalent |
| K151156 | Fiagon Navigation System | Apr 1, 2016 | Substantially Equivalent |
| K160479 | PointerShell Universal, PointerShell LS | Mar 23, 2016 | Substantially Equivalent |
| K160369 | GuideWire | Mar 10, 2016 | Substantially Equivalent |
| K150473 | FlexPointer 1.5 mm | Apr 16, 2015 | Substantially Equivalent |
| K133573 | FIAGON NAVIGATION SYSTEM | Apr 30, 2014 | Substantially Equivalent |