Fujifilm
FUJIFILM Endoscope Model EI-740D/S is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus,…
FUJIFILM Endoscope Model EI-740D/S is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
9manufacturers in China registered for this device type
43catalogue numbers in this listing
15510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| 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 |
| Sumitomo Bakelite (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | FDS |
| Device type | Gastroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K142629 |
| Record published | 2016-12-14 |
| 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 | Handling environment atmospheric pressure 70 to 106 KiloPascal; Special storage condition: There must be no condensation.; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 85 % RH; Storage environment humidity 30 to 85 % RH |
| Packaging | Box, box of 5, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| EG-530CT | In distribution | ||
| EG-530N | In distribution | ||
| DH-40GR | In distribution | ||
| DH-126STL | In distribution | ||
| EG-450D5 | In distribution | ||
| DH-37CZ | In distribution | ||
| EG-530UR2 | In distribution | ||
| DH-084STR | In distribution | ||
| B20UT | 20 | In distribution | |
| DH-116STL | In distribution | ||
| EG-840TP | In distribution | ||
| DH-094STR | In distribution | ||
| DH-124STR | In distribution | ||
| DH-114STR | In distribution | ||
| EG-450CT5 | In distribution | ||
| EG-860R | In distribution | ||
| EG-530D | In distribution | ||
| EI-740D/S | In distribution | ||
| DH-096ST | In distribution | ||
| DH-28GR | In distribution | ||
| DH-39CZ | In distribution | ||
| EG-450PE5 | In distribution | ||
| EG-740N | In distribution | ||
| EG-600WR v2 | In distribution | ||
| EG-530WR | In distribution | ||
| EG-600WR | In distribution | ||
| B20UR | 20 | In distribution | |
| EC-740T/L | In distribution | ||
| EC-760ZP-V/L | In distribution | ||
| DH-083ST | In distribution | ||
| DH-34CR | In distribution | ||
| EG-S100XT | In distribution | ||
| EC-760R-V/L | In distribution | ||
| EG-840N | In distribution | ||
| DH-104STR | In distribution | ||
| EG-840T | In distribution | ||
| DH-30CR | In distribution | ||
| EC-760P-V/L | In distribution | ||
| EG-530UT2 | In distribution | ||
| EG-530NP | In distribution | ||
| EI-580BT | In distribution | ||
| DH-134STR | In distribution | ||
| DH-106STL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pentax | Hoya Corporation | 72 |
| Disposable Distal Attachment | Olympus Medical Systems Corp. | 27 |
| Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 26 |
| Video Gastroscope | Pentax of America, Inc. | 20 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 18 |
| Medisono | Medisono, LLC | 18 |
| Gastroscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 17 |
| Distal Attachment | Olympus Medical Systems Corp. | 14 |
| Disposable EMR KIT | Olympus Medical Systems Corp. | 12 |
| Fuse® | Endochoice, Inc. | 11 |
| Evis Exera II Gastrointestinal Videoscope | Olympus Medical Systems Corp. | 9 |
| Pentax Medical | Hoya Corporation | 9 |
Showing 12 of 66. All products under Gastroscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250550 | 2026-02-17 |
| K253568 | 2026-02-06 |
| K243512 | 2025-06-10 |
| K242779 | 2024-10-11 |
| K240142 | 2024-09-04 |
| K212296 | 2021-08-19 |
| K210162 | 2021-04-09 |
| K200850 | 2020-07-06 |
| K193123 | 2019-12-11 |
| K183572 | 2019-07-16 |
| K182836 | 2019-04-02 |
| K183686 | 2019-02-28 |
| K180341 | 2018-08-03 |
| K181763 | 2018-07-27 |
| K172916 | 2018-03-01 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fujinon, Inc. | 510(k) number | 2013-07-31 | Class II | Unknown/Undetermined by firm | A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope. | 12 Units | 2014-03-04 |
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.