FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
SURGICASE GUIDE
K Number: K111558
·
Decision Mar 27, 2012
Classifications
1
FEI Numbers
246
Registration Numbers
246
Same Product Code
417
Applicant Total
26
Review Days
298
Basic Information
- Device Name
- SURGICASE GUIDE
- K Number
- K111558
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MATERIALISE N.V.
- Date Received
- June 3, 2011
- Decision Date
- March 27, 2012
- Product Code
- HAW
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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