Suction Valve MAJ-1443
The Olympus MAJ-1443 Suction Valve controls suction through a compatible gastrointestinal ultrasound endoscope. It is used to remove fluids, debris or air from the patient and to remove…
The Olympus MAJ-1443 Suction Valve controls suction through a compatible gastrointestinal ultrasound endoscope. It is used to remove fluids, debris or air from the patient and to remove water from the endoscope’s balloon.
The valve attaches to the suction cylinder of the endoscope. It is designed for the Olympus GF-UCT180 and GF-UE160-AL5 models and works as an accessory within their suction pathway.
Reuse and Contact
MAJ-1443 is reusable and has no patient-contacting components. Its role is suction control; lens washing and balloon filling are functions of the separately identified MAJ-1444 air/water valve.
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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | ODC |
| Device type | Endoscope Channel Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K250949 |
| Record published | 2025-09-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MAJ-1443 | 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 |
|---|---|
| K250949 | 2025-07-16 |
| K241842 | 2025-03-19 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2026-02-12 | Class II | Reprocessing Controls | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. | 47,383 units |
| Olympus Corporation of the Americas | 510(k) number | 2026-02-12 | Class II | Reprocessing Controls | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. | 89,579 units |
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.