510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240974Substantially Equivalent

SPRINT PNS System

SPR Therapeutics, Inc, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K240974 is the FDA 510(k) clearance record for SPRINT PNS System, a class II device, cleared for Spr Therapeutics, Inc. on under FDA product code SCN (Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief). FDA's definition for product code SCN reads: "A temporarily implanted peripheral nerve stimulation system for sustained pain relief is a prescription device that uses an external electrical stimulator(s) and percutaneous electrode(s) to stimulate a peripheral nerve(s) to provide...". FDA records list 7 510(k) clearances for Spr Therapeutics, Inc., from to . As of , FDA records show no recalls naming K240974.

Clearance record

Decision date
Received
(734 days to decision)
Product code
SCN Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
Regulation
21 CFR 882.5870
Device class
Class II
Review panel
Neurology
Applicant
Spr Therapeutics, Inc. 22901 Millcreek Blvd., Cleveland OH
Third party review
No

Clearances, product code SCN

Trailing 12 months
1 clearance under product code SCN in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SCN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260