UroMax Ultra Kit
Balloon Dilatation Catheter Kit
4manufacturers in China registered for this device type
16catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Seplou (Zhuhai) Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | KOE |
| Device type | Dilator, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2019-08-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0062251360 | 5 mm Diameter | In distribution |
| M0062251350 | 10 cm Effective Length | In distribution |
| M0062251310 | 30 F Diameter | In distribution |
| M0062251220 | 4 cm Effective Length | In distribution |
| M0062251210 | 5 mm Diameter | In distribution |
| M0062251250 | 30 F Diameter | In distribution |
| M0062251370 | 18 F Diameter | In distribution |
| M0062251230 | 4 cm Effective Length | In distribution |
| M0062251270 | 15 F Diameter | In distribution |
| M0062251260 | 12 F Diameter | In distribution |
| M0062251240 | 8 mm Diameter | In distribution |
| M0062251280 | 18 F Diameter | In distribution |
| M0062251200 | 12 F Diameter | In distribution |
| M0062251380 | 21 F Diameter | In distribution |
| M0062251290 | 7 mm Diameter | In distribution |
| M0062251300 | 8 mm Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 96 |
| Amplatz | Cook Incorporated | 66 |
| Wellead Urethral Dilator | Well Lead Medical Co., Ltd. | 17 |
| Peel-Away | Cook Incorporated | 15 |
| Dilator, Urethral | Richard Wolf Gmbh | 15 |
| V. Mueller | Steris Corporation | 14 |
| EZDilate | Gyrus Acmi, Inc. | 11 |
| QL Disposable Inflation Device | Atrion Medical Products, Inc. | 11 |
| UroMax Ultra | Boston Scientific Corporation | 11 |
| Flexor | Cook Incorporated | 10 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 6 |
| Optilume Basic Urological Dilation catheter | Urotronic Inc | 6 |
Showing 12 of 49. All products under Dilator, Urethral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K922349 | 1992-08-14 |
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 |
|---|---|---|---|---|---|---|
| Boston Scientific Corporation | UDI-DI | 2025-08-05 | Class II | Under Investigation by firm | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate | 1369 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.