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FDA 510(k)

SPRINT PNS System

K-Number: K240974 · 2026-04-14

ApplicantSpr Therapeutics, Inc.
Decision Date2026-04-14
Product CodeSCN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPRINT PNS System is a medical device manufactured by Spr Therapeutics, Inc.. It received FDA 510(k) clearance on 2026-04-14 under approval number K240974. The device is classified under product code SCN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPRINT PNS System?

SPRINT PNS System is a medical device that received FDA 510(k) clearance on 2026-04-14. It is manufactured by Spr Therapeutics, Inc.. The 510(k) number is K240974.

When was SPRINT PNS System approved by the FDA?

SPRINT PNS System received FDA 510(k) clearance on 2026-04-14, under approval number K240974.

What company makes SPRINT PNS System?

SPRINT PNS System is manufactured by Spr Therapeutics, Inc..

What is the FDA product code for SPRINT PNS System?

The FDA product code for SPRINT PNS System is SCN.

Related Clinical Trials

NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED

Other Devices by Spr Therapeutics, Inc.

K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit K211801SPRINT PNS System K202660SPRINT PNS System K223306SPRINT Peripheral Nerve Stimulation (PNS) System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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