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FDA 510(k)

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit

K-Number: K181422 · 2018-07-31

ApplicantSpr Therapeutics, Inc.
Decision Date2018-07-31
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit is a medical device manufactured by Spr Therapeutics, Inc.. It received FDA 510(k) clearance on 2018-07-31 under approval number K181422. 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 System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit?

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit is a medical device that received FDA 510(k) clearance on 2018-07-31. It is manufactured by Spr Therapeutics, Inc.. The 510(k) number is K181422.

When was SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit approved by the FDA?

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit received FDA 510(k) clearance on 2018-07-31, under approval number K181422.

What company makes SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit?

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit is manufactured by Spr Therapeutics, Inc..

What is the FDA product code for SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit?

The FDA product code for SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit is NHI.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Spr Therapeutics, Inc.

K211801SPRINT PNS System K202660SPRINT PNS System K223306SPRINT Peripheral Nerve Stimulation (PNS) System K240974SPRINT PNS System

Related Devices (Code: NHI)

K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 PacksSpr Therapeutics, LLC K170902Sprint 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 KitSpr Therapeutics, LLC K212859First ReliefDyansys, Inc. K211801SPRINT PNS SystemSpr Therapeutics, Inc. K202660SPRINT PNS SystemSpr Therapeutics, Inc. K221425Primary ReliefDyansys, 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.

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