510(k) K240974

Device

SPRINT PNS System

Applicant

Spr Therapeutics, Inc.

510(k) number

K240974

Product code

SCN

Decision

Substantially Equivalent (SESE)

Decision date

2026-04-14

Date received

2024-04-10

Regulation

882.5870

Classification name

Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief

Medical specialty

Neurology

Review panel

Neurology

Device class

2

Clearance type

Traditional

Third party reviewed

N