Sparrow Ascent 313-k

GUDID 00850052017552

Sparrow Ascent Kit - B2C (Mastoid Left 7)

Spark Biomedical Inc.

Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

• Primary Device ID: 00850052017552
• NIH Device Record Key: ebdc3033-1e77-4940-934e-802eaf78f160
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sparrow Ascent
• Version Model Number: 313
• Catalog Number: 313-k
• Company DUNS: 074715155
• Company Name: Spark Biomedical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850052017552 [Primary]

FDA Product Code

• PZR: Percutaneous Nerve Stimulator For Opioid Withdrawal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-10
• Device Publish Date: 2026-02-02

Devices Manufactured by Spark Biomedical Inc.

• 00850052017552 - Sparrow Ascent: 2026-02-10Sparrow Ascent Kit - B2C (Mastoid Left 7)
• 00850052017552 - Sparrow Ascent: 2026-02-10 Sparrow Ascent Kit - B2C (Mastoid Left 7)
• 00850052017019 - Sparrow Ascent Earpiece, Right: 2023-09-15 The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ea
• 00850052017033 - Sparrow Ascent Replacement Kit: 2023-09-15 Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system
• 00850052017040 - Sparrow Ascent Cable: 2023-09-15 The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to
• 00850052017071 - Sparrow Ascent 28 Piece Kit (B2B): 2023-09-15 A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®).
• 00850052017088 - Sparrow Ascent 28 Piece Kit (B2C): 2023-09-15 A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®).
• 00860005396948 - Sparrow Ascent Kit (B2C): 2023-09-15 The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous
• 00860005396955 - Sparrow Ascent Patient Controller: 2023-09-15 The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasi