NaviAid™ Spark
An inflation system providing controlled inflation and deflation of the NaviAid™ AB balloon.
21manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (7), Shanghai (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
Showing 12 of 21. All 21 manufacturers in China registered for Endoscope Channel Accessory
Record
| Listed by | Smart Medical Systems Ltd., Israel |
|---|---|
| FDA product code | ODC |
| Device type | Endoscope Channel Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K112106 |
| Record published | 2020-12-01 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 0.7 to 1.1 millibar; Handling environment humidity 30 to 85 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 0.7 to 1.1 millibar; Storage environment humidity 0 to 85 % RH; Storage environment temperature 0 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPARK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CeroFrict | SML MED-Tech Solutions Limited | 60 |
| Disposable Endoscopy Adapter Sets | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 14 |
| andorate® Biopsy Valve | GA Health Company Limited | 8 |
| andorate® 4-piece Valve Kit | GA Health Company Limited | 8 |
| Cook | Cook Incorporated | 7 |
| Water Jet Adapter | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 7 |
| andorate® 3-piece Valve Kit | GA Health Company Limited | 7 |
| Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit | GA Health Company Limited | 7 |
| Defendo Single Use Valve Kit | Medivators Inc | 6 |
| Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory) | 6 |
| Andorate | Smartdata Suzhou Co., Ltd. | 6 |
| BullDog® | Diversatek Healthcare Inc | 6 |
Showing 12 of 89. All products under Endoscope Channel Accessory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112106 | 2012-02-06 |
| K111760 | 2011-08-09 |
| K110291 | 2011-06-17 |
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.