Optilume Basic Urological Dilation Catheter
The Optilume Basic Urological Balloon Dilation Catheter widens narrowed segments of the urethra. It is an over the wire catheter compatible with a 0.038 inch guidewire and the working…
The Optilume Basic Urological Balloon Dilation Catheter widens narrowed segments of the urethra. It is an over the wire catheter compatible with a 0.038 inch guidewire and the working channel of a standard flexible cystoscope.
A semicompliant balloon near the distal end expands with saline or contrast inflation fluid and applies radial force to the stricture. The dual lumen catheter has a tapered atraumatic tip and a usable length of 75 cm.
Listed Item
The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038” (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.
Positioning and Supply
Two radiopaque marker bands identify the balloon’s working section during fluoroscopy. Cystoscopic visualization can also guide placement. The catheter is supplied sterile after ethylene oxide processing and is intended for one use.
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 | Urotronic Inc, United States |
|---|---|
| FDA product code | KOE |
| Device type | Dilator, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Manufacturer |
| 510(k) | K191061 |
| Record published | 2025-07-18 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1147 | In distribution | |
| 1147 | In distribution | |
| 1147 | In distribution | |
| 1147 | In distribution | |
| 1147 | In distribution | |
| 1147 | 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 |
| UroMax Ultra Kit | Boston Scientific Corporation | 16 |
| 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 |
Showing 12 of 49. All products under Dilator, Urethral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191061 | 2020-01-02 |
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.