Identity
- Trade Name
- Sparrow Ascent 28 Piece Kit (B2C) FDA UDI
- Generic Name
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
- Device Name
- A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993 FDA UDI
- Model / Reference
- 11-310-K-28 FDA UDI
- Description
- A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850052017088 FDA UDI
- 510(k) Number
- K230796 FDA UDI
- FDA Product Code
- PZR FDA UDI
- GMDN Term
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5896 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Sparrow Ascent 28 Piece Kit (B2C) by Spark Biomedical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator.
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- Sparrow Ascent Cable — Spark Biomedical Inc. · Class II
Cleared under the same submission
K230796 also covers:
- Sparrow Ascent 28 Piece Kit (B2B) — Spark Biomedical Inc.
- Sparrow Ascent Cable — Spark Biomedical Inc.
- Sparrow Ascent Cable — Spark Biomedical Inc.
- Sparrow Ascent Earpiece, Left — Spark Biomedical Inc.
- Sparrow Ascent Earpiece, Right — Spark Biomedical Inc.
- Sparrow Ascent Patient Controller — Spark Biomedical Inc.
- Sparrow Ascent Replacement Kit — Spark Biomedical Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spark Biomedical Inc.
Sources (1)
- FDA UDI d473e168-f8b2-4497-be2e-86d43eaab33e 34 fields · synced May 30, 2026