FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPID PROGRAMMER
K Number: K113611
·
Decision Apr 20, 2012
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
105
Review Days
136
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Basic Information
- Device Name
- RAPID PROGRAMMER
- K Number
- K113611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- St Jude Medical
- Date Received
- December 6, 2011
- Decision Date
- April 20, 2012
- Product Code
- GZB
- 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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZB), ordered by most recent decision date.
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
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