FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
K Number: K082010
·
Decision Dec 29, 2008
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
17
Applicant Total
2
Review Days
167
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Basic Information
- Device Name
- STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
- K Number
- K082010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4305
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Ireland Ltd., Instruments Division
- Date Received
- July 15, 2008
- Decision Date
- December 29, 2008
- Product Code
- HBF
- 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 |
|---|---|---|---|
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | FDA class 2 | Neurology |
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Other Clearances by Stryker Ireland Ltd., Instruments Division
| K Number | Device Name | ||
|---|---|---|---|
| K073633 | STRYKER ESSX MICRODEBRIDER SYSTEM | Aug 26, 2008 | Substantially Equivalent |