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FDA 510(k)

SPRINT PNS System

K-Number: K211801 · 2021-10-13

ApplicantSpr Therapeutics, Inc.
Decision Date2021-10-13
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPRINT 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 2021-10-13 under 510(k) number K211801. 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 PNS System?

SPRINT PNS System is a medical device that received FDA 510(k) clearance on 2021-10-13. The listed applicant is Spr Therapeutics, Inc.. The 510(k) number is K211801.

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

SPRINT PNS System received FDA 510(k) clearance on 2021-10-13, under 510(k) number K211801.

Who is the listed applicant for SPRINT 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 PNS System?

The FDA product code for SPRINT 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.

NCT05491915The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head PainACTIVE_NOT_RECRUITINGNCT04246281The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back PainCOMPLETED

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 SystemK223306SPRINT Peripheral Nerve Stimulation (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.

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

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