FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPINAL CORD STIMULATION SYS SE-4
K Number: K833990
·
Decision Mar 19, 1984
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
475
Review Days
119
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Basic Information
- Device Name
- SPINAL CORD STIMULATION SYS SE-4
- K Number
- K833990
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Medtronic Vascular
- Date Received
- November 21, 1983
- Decision Date
- March 19, 1984
- 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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Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
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