Identity
- Trade Name
- Optilume Basic Urological Dilation catheter FDA UDI
- Generic Name
- Urethral dilator, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1147 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 1147-10050 FDA UDI
- Primary DI / UDI-DI
- 00853095008396 FDA UDI
- 510(k) Number
- K191061 FDA UDI
- FDA Product Code
- KOE FDA UDI
- GMDN Term
- Urethral dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Urethral dilator, single-use
Optilume Basic Urological Dilation catheter by Urotronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urethral dilator, single-use.
- Wellead Urethral Dilator — Well Lead Medical Co., Ltd · Class II
- Wellead Urethral Dilator — Well Lead Medical Co., Ltd · Class II
- Wellead Urethral Dilator — Well Lead Medical Co., Ltd · Class II
- Wellead Urethral Dilator — Well Lead Medical Co., Ltd · Class II
- Wellead Urethral Dilator — Well Lead Medical Co., Ltd · Class II
- Wellead Urethral Dilator — Well Lead Medical Co., Ltd · Class II
- Dornier MedTech — Dornier MedTech America, Inc. · Class II
- Dornier MedTech — Dornier MedTech America, Inc. · Class II
Cleared under the same submission
K191061 also covers:
- Optilume Basic Urological Dilation catheter — Urotronic, Inc.
- Optilume Basic Urological Dilation catheter — Urotronic, Inc.
- Optilume Basic Urological Dilation catheter — Urotronic, Inc.
- Optilume Basic Urological Dilation catheter — Urotronic, Inc.
- Optilume Basic Urological Dilation catheter — Urotronic, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Urotronic, Inc.
Sources (1)
- FDA UDI abf13f00-7b3f-4d13-885d-bbda7fd1f1ef 35 fields · synced Jun 8, 2026