SPRINT Peripheral Nerve Stimulation (PNS) System— 510(k) K223306

Name: FDA 510(k) clearance K223306
Creator: U.S. Food and Drug Administration
Published: 2023-01-25

Substantially Equivalent

Spr Therapeutics, Inc.

FDA 510(k) clearance K223306 for SPRINT Peripheral Nerve Stimulation (PNS) System, Substantially Equivalent on 2023-01-25. Applicant: Spr Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Spr Therapeutics, Inc.
Product code: Code NHI
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2022-10-27
Decision date: 2023-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHI

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K221425 — Primary Relief2022-09-13
K220397 — ANSiStim-PP2022-05-12
K213188 — Primary Relief2022-01-31
K212859 — First Relief2021-12-20
K211801 — SPRINT PNS System2021-10-13

More clearances from Spr Therapeutics, Inc.

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K240974 — SPRINT PNS System2026-04-14
K202660 — SPRINT PNS System2021-01-22
K181422 — SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit2018-07-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.