VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
FDA 510(k) clearance K092467 · decided 2010-05-06
Clearance details
- K-number
- K092467
- Device name
- VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2009-08-12
- Decision date
- 2010-05-06
- Days to decision
- 267 days
- Clearance type
- Special
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Feldkirchen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiolo recall (Z-0598-2016) | Brainlab AG | 2016-01-19 |