Decision Date2021-10-13
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SPRINT PNS System is a medical device manufactured by Spr Therapeutics, Inc.. It received FDA 510(k) clearance on 2021-10-13 under approval 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. It is manufactured by Spr Therapeutics, Inc.. The 510(k) number is K211801.
When was SPRINT PNS System approved by the FDA?
SPRINT PNS System received FDA 510(k) clearance on 2021-10-13, under approval number K211801.
What company makes SPRINT PNS System?
SPRINT PNS System is manufactured by Spr Therapeutics, Inc..
What is the FDA product code for SPRINT PNS System?
The FDA product code for SPRINT PNS System is NHI.
Other Devices by Spr Therapeutics, Inc.
Related Devices (Code: NHI)
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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
K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer KitSpr Therapeutics, Inc.
K212859First ReliefDyansys, Inc.
K202660SPRINT PNS SystemSpr Therapeutics, Inc.
K221425Primary ReliefDyansys, Inc.
Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.