Arthromatic/Uromatic
Y-Type TUR/Bladder Irrigation Set, Regulating Clamp
8manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | LJH |
| Device type | System, Irrigation, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K960787 |
| Record published | 2016-09-24 |
| Record revised | 2026-07-03 (version 8) |
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 |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2C4041 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Irrigation Set | B. Braun Medical Inc. | 11 |
| Medline | Medline Industries, Inc. | 6 |
| MED-RX | Canadian Hospital Specialties Ltd. | 3 |
| AMSure ® Four Lead Bladder Irrigation Set | Amsino Medical Inc. | 2 |
| Asurys™ | Boston Scientific Corporation | 2 |
| AMSure® Cystoscopy/Bladder Irrigation Set | Amsino Medical Inc. | 2 |
| Flo-Assist II | Northgate Technologies Inc. | 1 |
| Centurion | Centurion Medical Products Corporation | 1 |
| Avid TruCustom | Avid Medical, Inc. | 1 |
| Equimat | Karl Storz GmbH & Co. KG | 1 |
| System, Irrigation, Urological | Karl Storz GmbH & Co. KG | 1 |
| AMSure® TUR/Bladder Irrigation Set Y-Type | Amsino Medical Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960787 | 1996-05-14 |
Recalls Naming This Product
3 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 | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 510(k) number | 2013-05-15 | Class II | Packaging | A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging. | 356,728 units | 2015-06-16 |
| Baxter Healthcare Corporation | 510(k) number | 2013-05-15 | Class II | Packaging | A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging. | 530,488 units | 2015-06-16 |
| Baxter Healthcare Corporation | 510(k) number | 2013-05-15 | Class II | Packaging | A firm’s internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging. | 249,576 units | 2015-06-16 |
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.