Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPRINT Peripheral Nerve Stimulation (PNS) System

K-Number: K223306 · 2023-01-25

ApplicantSpr Therapeutics, Inc.
Decision Date2023-01-25
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPRINT Peripheral Nerve Stimulation (PNS) System is the device name listed in this FDA 510(k) record. The listed applicant is Spr Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K223306. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPRINT Peripheral Nerve Stimulation (PNS) System?

SPRINT Peripheral Nerve Stimulation (PNS) System is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Spr Therapeutics, Inc.. The 510(k) number is K223306.

When did SPRINT Peripheral Nerve Stimulation (PNS) System receive FDA 510(k) clearance?

SPRINT Peripheral Nerve Stimulation (PNS) System received FDA 510(k) clearance on 2023-01-25, under 510(k) number K223306.

Who is the listed applicant for SPRINT Peripheral Nerve Stimulation (PNS) System?

The FDA 510(k) record lists Spr Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPRINT Peripheral Nerve Stimulation (PNS) System?

The FDA product code for SPRINT Peripheral Nerve Stimulation (PNS) System is NHI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04246281The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back PainCOMPLETEDNCT05491915The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head PainACTIVE_NOT_RECRUITINGNCT01207336Combined tDCS+PNS After Acute StrokeCOMPLETEDNCT06741579Mechanisms of Stimulation for Pain AlleviationRECRUITINGNCT07637682Percutaneous Neurostimulation in Knee OsteoarthritisRECRUITING

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 26394389Regulation of Peripheral Nerve Stimulation Technology.Progress in neurological surgery (2015)

Other records listing Spr Therapeutics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240974SPRINT PNS SystemK211801SPRINT PNS SystemK202660SPRINT PNS SystemK181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer KitK170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator KitK161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

View all 7 devices →

Related Devices (Code: NHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221425Primary ReliefDyansys, Inc.K220397ANSiStim-PPDyansys, Inc.K213188Primary ReliefDyansys, Inc.K212859First ReliefDyansys, Inc.K211801SPRINT PNS SystemSpr Therapeutics, Inc.K202660SPRINT PNS SystemSpr Therapeutics, Inc.

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.

↑