Single USE Ligating Device
2 catalogue numbers from HX-400U-30, listed by Olympus Medical Systems Corp., Japan, under Ligator, Esophageal. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Beijing (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | MND |
| Device type | Ligator, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2023-08-28 (version 6) |
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 |
| Packaging | Pack of 5, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HX-400U-30 | In distribution | |
| HX-400U-30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zksk | Beijing Zksk Technology Co., Ltd. | 48 |
| Saeed | Cook Incorporated | 27 |
| Multiple Band Ligator Set | Micro-Tech (Nanjing) Co., Ltd. | 24 |
| Single Use Rotatable Clip Fixing Device | Olympus Medical Systems Corp. | 22 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| Auto-Band® | Endochoice, Inc. | 4 |
| Tube Sheath | Olympus Medical Systems Corp. | 3 |
| Rotatable Clip Fixing Device | Olympus Medical Systems Corp. | 3 |
| Stiegmann-Goff | ConMed Corporation | 3 |
| Ligating Device | Olympus Medical Systems Corp. | 3 |
| Loop | Olympus Medical Systems Corp. | 2 |
| Stiegmann-Goff Bandito | ConMed Corporation | 1 |
Showing 12 of 17. All products under Ligator, Esophageal
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2025-10-30 | Class I | Process control | Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy. | 7803 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.