Identity
- Trade Name
- NaviAid™ SPARKC FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, reusable FDA UDI
- Device Name
- The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel. FDA UDI
- Model / Reference
- SPARKC FDA UDI
- Description
- The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel. FDA UDI
Identifiers
- Catalog Number
- 40-016 FDA UDI
- Primary DI / UDI-DI
- 07290018671504 FDA UDI
- 510(k) Number
- K202469 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, reusable 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Catheter/overtube balloon inflator, reusable
NaviAid™ SPARKC by Smart Medical Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Catheter/overtube balloon inflator, reusable.
- RESERVOIR TANK — Olympus Medical Systems Corporation · Class II
- BALLOON CONTROL UNIT — Olympus Medical Systems Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Pneumatic Inflator — Boston Scientific · Class I
- NaviAid™ SPARK — SMART MEDICAL SYSTEMS LTD · Class II
Cleared under the same submission
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
- Smart Medical Systems Ltd
Sources (1)
- FDA UDI f8df187f-e162-4377-85ac-866d4e72edec 37 fields · synced Jun 8, 2026