DeviceClearance

SPRINT PNS System— 510(k) K240974

Substantially Equivalent

Spr Therapeutics, Inc.

FDA 510(k) clearance K240974 for SPRINT PNS System, Substantially Equivalent on 2026-04-14. Applicant: Spr Therapeutics, Inc.. Device class: 2.

Summary

Spr Therapeutics' SPRINT PNS System is filed under product code SCN (Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 882.5870. Neurology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Spr Therapeutics filed from Cleveland, Ohio. The record shows 734 calendar days from receipt to decision (April 10, 2024 to April 14, 2026).

Clearance details

Applicant
Spr Therapeutics, Inc.
Product code
Product code SCN
Device class
Class 2
Regulation
21 CFR 882.5870
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cleveland, OH, US
Download summary PDFView on FDA.gov ↗

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