Fujifilm
This product is used in combination with FUTIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is…
This product is used in combination with FUTIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the digestive tract from the mouth or anus to stabilize the distal end of the endoscope to the digestive tract’s mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates , infants or children
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 | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K193123 |
| Record published | 2020-01-30 |
| Record revised | 2025-12-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, High-level Disinfectant |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Special storage condition: There must be no condensation.; Storage environment humidity 10 to 95 % RH |
| Packaging | Box, box of 10, box of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DH-38CZ | In distribution | ||
| DH-33GR | In distribution | ||
| EC-530DL | In distribution | ||
| TY-06D | In distribution | ||
| EC-600WL v2 | In distribution | ||
| EN-580T | In distribution | ||
| EC-450LP5 | In distribution | ||
| DH-29CR | In distribution | ||
| DH-35GZ | In distribution | ||
| TS-1314B | In distribution | ||
| EC-530HL V2 | In distribution | ||
| JA-500 | In distribution | ||
| EC-760S-V/L | In distribution | ||
| TY-04D | In distribution | ||
| DH-32EN | In distribution | ||
| DH-17EN | 10 | In distribution | |
| EC-450DL5 | In distribution | ||
| TY-500D | In distribution | ||
| TS-13140 | In distribution | ||
| EC-600LS | In distribution | ||
| EC-760Z-V/L | In distribution | ||
| EC-450BI5 | In distribution | ||
| EG-760R | In distribution | ||
| JT-500 | In distribution | ||
| EG-760CT | In distribution | ||
| WT-4 | In distribution | ||
| DH-17EN2 | In distribution | ||
| EW10-VM01 | In distribution | ||
| EC-860P/M | In distribution | ||
| EG-760Z | In distribution | ||
| EC-860P/L | In distribution | ||
| EC-600HL | In distribution | ||
| BS-4 | In distribution | ||
| EC-600WL | In distribution | ||
| EC-530HL2 | In distribution | ||
| PB-30 | In distribution | ||
| EC-530LS2 | In distribution | ||
| WT-603 | In distribution | ||
| EC-530LS V2 | In distribution | ||
| EC-860S/L | 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 |
| 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 |
| Flex | Medrobotics Corporation | 10 |
Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243261 | 2025-05-23 |
| K223827 | 2023-09-08 |
| K192664 | 2019-11-20 |
| K190649 | 2019-05-07 |
| K180405 | 2018-03-15 |
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.