FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K202274
·
Decision Nov 9, 2020
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
138
Applicant Total
6
Review Days
90
Basic Information
- Device Name
- 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
- K Number
- K202274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nalu Medical, Inc.
- Date Received
- August 11, 2020
- Decision Date
- November 9, 2020
- 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 |
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Other Clearances by Nalu Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Aug 21, 2024 | Substantially Equivalent |
| K221376 | Nalu Neurostimulation System | Jun 10, 2022 | Substantially Equivalent |
| K203547 | Nalu Neurostimulation System | Mar 25, 2021 | Substantially Equivalent |
| K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 | Sep 6, 2019 | Substantially Equivalent |
| K190960 | Nalu Lead Blank (50cm) | Jul 11, 2019 | Substantially Equivalent |