FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NBD DISPOSABLE RF CANNULAE
K Number: K032196
·
Decision Oct 9, 2003
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
65
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- NBD DISPOSABLE RF CANNULAE
- K Number
- K032196
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- New Business Development, LLC
- Date Received
- July 18, 2003
- Decision Date
- October 9, 2003
- Product Code
- GXI
- 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 |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | FDA class 2 | Neurology |
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