Identity
- Trade Name
- Sparrow Ascent Cable FDA UDI
- Generic Name
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
- Device Name
- 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. This is a subcomponent and is not transacted. See 810-P. FDA UDI
- Model / Reference
- 810 FDA UDI
- 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. This is a subcomponent and is not transacted. See 810-P. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005396979 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Sparrow Ascent Cable by Spark Biomedical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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 |
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Manufacturer
- Manufacturer
- Spark Biomedical Inc.
Sources (1)
- FDA UDI f7b5b453-35fc-4069-b2b1-86e922bb179b 34 fields · synced May 30, 2026