G-EYE Colonoscope
The G-EYE colonoscope is used for examination and endoscopic procedures in the lower gastrointestinal tract. It incorporates an inflatable balloon near the bending section to help center…
The G-EYE colonoscope is used for examination and endoscopic procedures in the lower gastrointestinal tract. It incorporates an inflatable balloon near the bending section to help center the viewing optics and stabilize positioning within the colon.
The endoscopist advances the scope with the balloon deflated. During withdrawal, the balloon is inflated to engage the colon wall and straighten folds and bends. A dedicated NaviAid SPARKC pump controls balloon pressure at the selected level.
Listed Item
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.
Equipment and Reprocessing
The colonoscope is used with compatible video processing, illumination and display equipment. It is reusable and must be reprocessed using the underlying endoscope manufacturer’s instructions together with the additional instructions for the G-EYE balloon.
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) | K220158 |
| Record published | 2023-07-18 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -47 to 70 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 85 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G-EYEH180AL | In distribution | |
| G-EYEH190L | In distribution | |
| G-EYE760Z-V/L | In distribution | |
| G-EYEHQ190L | In distribution | |
| G-EYE760P-V/L | In distribution | |
| G-EYEH180I | In distribution | |
| G-EYEQ180AL | In distribution | |
| G-EYE3890LZi | In distribution | |
| G-EYEQ180AL | In distribution | |
| G-EYE3890Li | In distribution | |
| G-EYEHQ190L | In distribution | |
| G-EYE760R-V/L | In distribution | |
| G-EYEH190I | In distribution | |
| G-EYEHQ190I | In distribution | |
| G-EYE760ZP-V/L | In distribution | |
| G-EYEH180AL | In distribution | |
| G-EYEQ180AI | In distribution | |
| G-EYE38-i10L | In distribution | |
| G-EYEHQ190I | In distribution | |
| G-EYEH190I | In distribution | |
| G-EYE760S-V/L | In distribution | |
| G-EYEH190L | In distribution | |
| G-EYEH180AI | In distribution | |
| G-EYEQ180I | 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 |
| 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 |
| Flex | Medrobotics Corporation | 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.