NaviAid™ Sparkc
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®…
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.
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dalian Create Medical Products Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 2 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Smart Medical Systems Ltd., Israel |
|---|---|
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K202469 |
| Record published | 2020-12-02 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 0.9 to 1.1 millibar; Storage environment atmospheric pressure 0.9 to 1.1 millibar; Storage environment humidity 0 to 85 % RH; Storage environment temperature 0 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPARKC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fuse | Endochoice, Inc. | 52 |
| Colonoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 51 |
| Fujifilm | Fujifilm Corporation | 40 |
| Pentax | Hoya Corporation | 37 |
| Video Colonoscope | Pentax of America, Inc. | 25 |
| G-EYE Colonoscope | Smart Medical Systems Ltd. | 24 |
| Medisono | Medisono, LLC | 18 |
| Evis Exera lll Colonovideoscope | Olympus Medical Systems Corp. | 16 |
| Endoch | Endoch Inc | 14 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonoscope And Accessories, Flexible/Rigid | Hangzhou AGS MedTech Co., Ltd. | 10 |
Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220158 | 2022-04-11 |
| K202469 | 2020-10-26 |
| K192588 | 2020-04-15 |
| K102616 | 2010-12-30 |
| K101191 | 2010-07-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.