Identity
- Trade Name
- NaviAid™ AB FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestine while utilizing the existing endoscope optics and utilities. The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through the instrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloon air supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of the balloon.The NaviAid™ AB Device is indicated for use in adults and adolescent population. FDA UDI
- Model / Reference
- AB-F FDA UDI
- Description
- The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestine while utilizing the existing endoscope optics and utilities. The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through the instrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloon air supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of the balloon.The NaviAid™ AB Device is indicated for use in adults and adolescent population. FDA UDI
Identifiers
- Catalog Number
- 24-010 FDA UDI
- Primary DI / UDI-DI
- 07290018671603 FDA UDI
- 510(k) Number
- K112106 FDA UDI
- FDA Product Code
- ODC FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Catheter/overtube balloon inflator, single-use
NaviAid™ AB by Smart Medical Systems Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K112106 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Smart Medical Systems Ltd
Sources (2)
- FDA UDI f47b0356-749f-46c7-a645-f81ca127b515 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026