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FDA 510(k)

Sprint 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 Kit

K-Number: K170902 · 2017-06-26

ApplicantSpr Therapeutics, LLC
Decision Date2017-06-26
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sprint 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 Kit is the device name listed in this FDA 510(k) record. The listed applicant is Spr Therapeutics, LLC. It received FDA 510(k) clearance on 2017-06-26 under 510(k) number K170902. 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 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 Kit?

Sprint 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 Kit is a medical device that received FDA 510(k) clearance on 2017-06-26. The listed applicant is Spr Therapeutics, LLC. The 510(k) number is K170902.

When did Sprint 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 Kit receive FDA 510(k) clearance?

Sprint 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 Kit received FDA 510(k) clearance on 2017-06-26, under 510(k) number K170902.

Who is the listed applicant for Sprint 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 Kit?

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

What is the FDA product code for Sprint 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 Kit?

The FDA product code for Sprint 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 Kit 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_RECRUITINGNCT06411054The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVARECRUITINGNCT07384741Using Virtual Reality During PICC and PICC-PORT Placement in Cancer PatientsACTIVE_NOT_RECRUITINGNCT07696507Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back PainNOT_YET_RECRUITING

Other records listing Spr Therapeutics, LLC 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 SystemK223306SPRINT Peripheral Nerve Stimulation (PNS) SystemK211801SPRINT PNS SystemK202660SPRINT PNS SystemK181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer 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.

K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.K221425Primary ReliefDyansys, Inc.K220397ANSiStim-PPDyansys, Inc.K213188Primary ReliefDyansys, Inc.K212859First ReliefDyansys, Inc.K211801SPRINT 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.

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