510(k) K181422
K181422 is an FDA 510(k) premarket notification submitted by Spr Therapeutics, Inc. for the device "SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit". The FDA issued a decision of Substantially Equivalent on July 31, 2018. The device falls under product code NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Spr Therapeutics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2018
- Date Received
- May 31, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,