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510(k) Data Aggregation
K Number
K223306Device Name
SPRINT Peripheral Nerve Stimulation (PNS) System
Manufacturer
SPR Therapeutics, Inc.
Date Cleared
2023-01-25
(90 days)
Product Code
NHI
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SPR Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days for:
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- Symptomatic relief of post-traumatic pain;
- Symptomatic relief of post-operative pain.
The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Device Description
The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
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K Number
K211801Device Name
SPRINT PNS System
Manufacturer
SPR Therapeutics, Inc.
Date Cleared
2021-10-13
(125 days)
Product Code
NHI
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SPR Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPRINT PNS System is indicated for up to 60 days for:
- · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- · Symptomatic relief of post-traumatic pain;
- · Symptomatic relief of post-operative pain.
The SPRINT PNS System is not intended to treat pain in the region innervated by the cranial and facial nerves.
Device Description
The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
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K Number
K202660Device Name
SPRINT PNS System
Manufacturer
SPR Therapeutics, Inc.
Date Cleared
2021-01-22
(130 days)
Product Code
NHI
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SPR Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for:
- · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- · Symptomatic relief of post-traumatic pain;
- · Symptomatic relief of post-operative pain.
The SPRINT PNS System is not intended to treat pain in the craniofacial region.
Device Description
The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
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K Number
K181422Device Name
SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
Manufacturer
SPR Therapeutics, Inc.
Date Cleared
2018-07-31
(61 days)
Product Code
NHI
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SPR Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for:
- · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- · Symptomatic relief of post-traumatic pain;
- · Symptomatic relief of post-operative pain.
The SPRINT PNS System is not intended to treat pain in the craniofacial region.
Device Description
The Sprint PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode. The Sprint PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, coiled, stainless steel wire designed to be percutaneously inserted via an introducer needle and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, stimulator programming by the clinician, and stimulator use by the patient.
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