EvoEndo Model LE Single-Use Gastroscope
The EvoEndo Model LE is a sterile, single-use gastroscope for viewing the upper digestive tract. It can be inserted through the mouth or nose in adults and children over five years old for…
The EvoEndo Model LE is a sterile, single-use gastroscope for viewing the upper digestive tract. It can be inserted through the mouth or nose in adults and children over five years old for observation, diagnosis and endoscopic treatment of the esophagus, stomach and duodenal bulb.
A camera at the distal tip captures images and video, which the EvoEndo Controller processes for display on a medical monitor. Controls on the handle steer the tip in four directions and operate air, water, suction and image capture functions.
Accessory Channel and Preparation
The gastroscope has a working channel compatible with standard accessories and a working length greater than one meter. Its umbilical bundle contains air, water and suction lines together with the video connector. Each endoscope is individually packaged and sterilized with ethylene oxide.
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 | Evoendo, Inc., United States |
|---|---|
| FDA product code | FDS |
| Device type | Gastroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K213606 |
| Record published | 2022-02-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment atmospheric pressure 80 to 109 KiloPascal; Storage environment humidity 30 to 85 % RH; Storage environment temperature 10 to 40 °C |
| Sizes | Outer diameter 3.5 mm; lumen/inner diameter 2 mm; length 1.1 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LE | Outer Diameter 3.5 mm | In distribution |
| LE | Outer Diameter 3.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pentax | Hoya Corporation | 72 |
| Fujifilm | Fujifilm Corporation | 43 |
| 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 |
Showing 12 of 66. All products under Gastroscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260573 | 2026-04-21 |
| K251708 | 2025-10-10 |
| K250900 | 2025-06-16 |
| K213606 | 2022-02-14 |
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.