FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GuardianTM Burr Hole Cover System
K Number: K181382
·
Decision Jul 20, 2018
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
105
Review Days
56
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Basic Information
- Device Name
- GuardianTM Burr Hole Cover System
- K Number
- K181382
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.5250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St Jude Medical
- Date Received
- May 25, 2018
- Decision Date
- July 20, 2018
- Product Code
- GXR
- 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 |
|---|---|---|---|
| GXR | Cover, Burr Hole | FDA class 2 | Neurology |
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