Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
FDA 510(k) clearance K161154 · decided 2016-07-23
Clearance details
- K-number
- K161154
- Device name
- Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
- Applicant
- Spr Therapeutics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-04-25
- Decision date
- 2016-07-23
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- NHI
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.