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FDA 510(k)

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

K-Number: K161154 · 2016-07-23

ApplicantSpr Therapeutics, LLC
Decision Date2016-07-23
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs 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 2016-07-23 under 510(k) number K161154. 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 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs?

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs is a medical device that received FDA 510(k) clearance on 2016-07-23. The listed applicant is Spr Therapeutics, LLC. The 510(k) number is K161154.

When did Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs receive FDA 510(k) clearance?

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs received FDA 510(k) clearance on 2016-07-23, under 510(k) number K161154.

Who is the listed applicant for Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs?

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 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs?

The FDA product code for Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs 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_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 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 Kit

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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