Olympus
EZDilate - Fixed Wire Esophageal 3-Stage Balloon Dilatation Catheter 13.5-15.5mm
9manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | KNQ |
| Device type | Dilator, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-04 |
| Record revised | 2024-12-23 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BD-400P-1880 | In distribution | |
| BD-400P-1580 | In distribution | |
| BD-400P-2080 | In distribution | |
| BD-400P-1080 | In distribution | |
| BD-400P-1380 | In distribution | |
| BD-400P-0880 | In distribution | |
| BD-410X-0855 | Withdrawn | |
| BD-410X-1355 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable Dilation Balloon | Micro-Tech (Nanjing) Co., Ltd. | 99 |
| Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 37 |
| Quantum TTC | Cook Incorporated | 27 |
| Savary Gilliard | Cook Incorporated | 26 |
| SafeGuide® | Diversatek Healthcare Inc | 25 |
| Eliminator | ConMed Corporation | 21 |
| ABC Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 21 |
| Flex-Ez Over the Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Flex-Ez Stylet Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Elation 5™ | Merit Medical Systems, Inc. | 18 |
| SafeGuide® Single | Diversatek Healthcare Inc | 16 |
| Conmed CleanGuide | Jiangsu Grit Medical Technology Co., Ltd. | 16 |
Showing 12 of 40. All products under Dilator, Esophageal
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2023-11-10 | Class II | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | 126 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-11-10 | Class II | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | 1796 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-11-10 | Class II | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | 1008 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-11-10 | Class II | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | 5232 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-11-10 | Class II | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | 5031 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-11-10 | Class II | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | 8294 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-11-10 | Class II | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | 1639 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-11-10 | Class II | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | 3354 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.