NaviAid™ SPARK
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SPARK EUDAMEDNaviAid™ SPARK FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, reusable FDA UDI
- Device Name
- SPARK EUDAMEDAn inflation system providing controlled inflation and deflation of the NaviAid™ AB balloon. FDA UDI
- Model / Reference
- SPARK Inflation System EUDAMED28-016 EUDAMEDSPARK FDA UDI
- Description
- An inflation system providing controlled inflation and deflation of the NaviAid™ AB balloon. FDA UDI
Identifiers
- Catalog Number
- 28-016 FDA UDI
- Primary DI / UDI-DI
- 07290018671528 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290018671SPARK8D EUDAMED
- Direct Marketing DI
- 07290018671528 EUDAMED
- 510(k) Number
- K112106 FDA UDI
- FDA Product Code
- ODC FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Catheter/overtube balloon inflator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Catheter/overtube balloon inflator, reusable
NaviAid™ SPARK by Smart Medical Systems Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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™ SPARKC — SMART MEDICAL SYSTEMS LTD · Class II
Cleared under the same submission
K112106 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 6d0c5c42-e116-4793-9883-5788fed7b9b9 37 fields · synced Jul 13, 2026
- EUDAMED f49d839e-4679-4c3c-8eed-1ae0faf4dc22 61 fields · synced Jul 13, 2026