FDA.reportPublic FDA data

Sparrow Ascent Cable

Primary DI
00850052017040
Brand
Sparrow Ascent Cable
Company
Spark Biomedical Inc.
Model
810-P
Device description
The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain.
Published
2023-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
PZRPercutaneous Nerve Stimulator For Opioid Withdrawal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZRPercutaneous Nerve Stimulator For Opioid WithdrawalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230796000Sparrow AscentSpark Biomedical, Inc.2023-06-20PZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850052017040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850052017040008500520170408500520170400850052017040

GMDN Terms#

Term, Definition table
TermDefinition
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulatorA body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways and structures [e.g., amygdala, spinal cord neurons]; depending on the treatment protocol and device settings it may be used for opioid withdrawal symptoms (e.g., bone/joint aches, tremor, anxiety), or irritable bowel syndrome [IBS]-associated functional abdominal pain (FAP). It consists of an electrical pulse generator with minimally-invasive electrodes, and accessories (e.g., adhesives, transilluminator). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
074715155
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850052017552Sparrow Ascent313313-k2026-02-02
00850052017019Sparrow Ascent Earpiece, Right2112023-09-07
00850052017033Sparrow Ascent Replacement Kit11-110-K2023-09-07
00850052017071Sparrow Ascent 28 Piece Kit (B2B)11-320-K-282023-09-07
00850052017088Sparrow Ascent 28 Piece Kit (B2C)11-310-K-282023-09-07
00860005396948Sparrow Ascent Kit (B2C)11-310-K2023-09-07
00860005396955Sparrow Ascent Patient Controller1102023-09-07
00860005396962Sparrow Ascent Earpiece, Left2102023-09-07
00860005396979Sparrow Ascent Cable8102023-09-07
00860005396986Sparrow Ascent Kit (B2B)11-320-K2023-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064311Morph DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-05-22
08908006064083Drug Relief v1NEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-03-16
08908006064205OpiEaseNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-03-16
00850052017552Sparrow AscentSpark Biomedical Inc.PZR2026-02-02
08908006064113Morph DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-20
08908006064120S.T. GenesisNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-20
08908006064106OpiReliefNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-19
00850052017019Sparrow Ascent Earpiece, RightSpark Biomedical Inc.PZR2023-09-07
00850052017033Sparrow Ascent Replacement KitSpark Biomedical Inc.PZR2023-09-07
00850052017071Sparrow Ascent 28 Piece Kit (B2B)Spark Biomedical Inc.PZR2023-09-07
00850052017088Sparrow Ascent 28 Piece Kit (B2C)Spark Biomedical Inc.PZR2023-09-07
00860005396948Sparrow Ascent Kit (B2C)Spark Biomedical Inc.PZR2023-09-07
00860005396955Sparrow Ascent Patient ControllerSpark Biomedical Inc.PZR2023-09-07
00860005396962Sparrow Ascent Earpiece, LeftSpark Biomedical Inc.PZR2023-09-07
00860005396979Sparrow Ascent CableSpark Biomedical Inc.PZR2023-09-07
00860005396986Sparrow Ascent Kit (B2B)Spark Biomedical Inc.PZR2023-09-07
B960NSS200NSS-2 BridgeNeuraxis, Inc.PZR2021-02-12
B960NSS2001NSS-2 BridgeInnovative Health Solutions, IncPZR2021-02-12
B327NSS200NSS-2KEY ELECTRONICS, INC.PZR2018-03-30