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510(k) K230796

Device
Sparrow Ascent
Applicant
Spark Biomedical, Inc.
510(k) number
K230796
Product code
PZR
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-20
Date received
2023-03-22
Regulation
882.5896
Classification name
Percutaneous Nerve Stimulator For Opioid Withdrawal
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brent Croft
Address
18208 Preston Rd. Suite D9-531 Dallas TX US 75252 75252

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251246Sparrow AscentSpark Biomedical, Inc.2025-08-25
K233166NET Recovery Corp/NET DeviceNet Recovery2024-05-29
K221231Drug Relief v1Dyansys, Inc.2022-06-06
K211971Drug Relief v1Dyansys, Inc.2021-11-05
K201873Sparrow Therapy SystemSpark Biomedical, Inc.2021-01-02
K173861Drug ReliefDyansys, Inc.2018-05-02
DEN170018NSS-2 SystemInnovative Health Solutions (Ihs), Inc.2017-11-15