Identity
- Trade Name
- Sparrow Ascent Replacement Kit FDA UDI
- Generic Name
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
- Device Name
- Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. FDA UDI
- Model / Reference
- 11-110-K FDA UDI
- Description
- Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850052017033 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
No
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 Replacement Kit 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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- NSS-2 Bridge — NEURAXIS, INC · Class II
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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 28 Piece Kit (B2C) — 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.
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 47726a31-1fab-4646-be26-b1a5b18bc051 34 fields · synced Jun 8, 2026