Optilume Basic Urological Balloon Dilation Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Optilume EUDAMED
- Device Name
- Optilume EUDAMED
- Model / Reference
- 1110 EUDAMED1110-06030C EUDAMED1110-08030C EUDAMED1110-10030C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00853095008815 EUDAMED00853095008792 EUDAMED00853095008761 EUDAMED
- Basic UDI-DI
- B-00853095008815 EUDAMEDB-00853095008792 EUDAMEDB-00853095008761 EUDAMED
- 510(k) Number
- K191061 FDA 510(k)
- FDA Product Code
- KOE FDA 510(k)
- EMDN Code
- U0399 DEVICES FOR URINARY TRACT DILATION - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5520 FDA 510(k)
- Regulation Number
- 876.5520 FDA 510(k)
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
Yes
The Optilume Basic Urological Balloon Dilation Catheter is a dilator, urethral (OpenFDA classification) designed for mechanical dilation of urethral strictures. It features a semi-compliant balloon that expands the urethral lumen, creating controlled micro-fissures to facilitate therapeutic interventions.
This over-the-wire (OTW) catheter, compatible with 0.038" (0.97 mm) guidewires and flexible cystoscopes, is supplied sterile and intended for single-use. The device includes a dual-lumen design with a tapered, atraumatic tip and is regulated under FDA 510(k) clearance (K191061) and the EU Medical Device Directive (MDD). Storage requires adherence to manufacturer guidelines for sterile packaging integrity.
Frequently asked questions
What is the primary clinical purpose of the Optilume Basic Urological Balloon Dilation Catheter, and how does it achieve this?
The Optilume Basic Urological Balloon Dilation Catheter is designed for mechanical dilation of urethral strictures, which are narrowings in the urethra. It achieves this through a semi-compliant balloon that expands the urethral lumen, creating controlled micro-fissures to facilitate therapeutic interventions and improve urine flow.
Is this catheter compatible with existing guidewires and cystoscopes, and if so, what are the specifications for compatibility?
Yes, the Optilume Basic Urological Balloon Dilation Catheter is compatible with 0.038-inch (0.97 mm) guidewires and flexible cystoscopes, allowing it to be used alongside standard diagnostic tools during procedures.
How is the Optilume Basic Urological Balloon Dilation Catheter supplied, and is it intended for single-use or reuse?
The catheter is supplied sterile and is explicitly intended for single-use only, ensuring patient safety and reducing the risk of contamination or cross-infection.
What storage requirements must be followed to maintain the sterility of the Optilume Basic Urological Balloon Dilation Catheter?
The device must be stored according to the manufacturer’s guidelines to preserve the integrity of its sterile packaging, preventing exposure to contaminants that could compromise its safety for single-use.
What regulatory pathways have been followed for the Optilume Basic Urological Balloon Dilation Catheter in the U.S. and Europe?
In the U.S., the catheter has received FDA clearance through a 510(k) submission (K191061) under the Traditional clearance type, while in Europe, it complies with the EU Medical Device Directive (MDD). Both pathways confirm its regulatory compliance for use in clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Optilume® for Urethral Stricture | Urethral Drug Coated Balloon - Laborie, PDF Instructions for Use Optilume Basic Urological Balloon Dilation Catheter, PDF Instructions for Use Optilume Basic Urological Balloon Dilation Catheter
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191061 | Class II | Active |
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Manufacturer
- Manufacturer
- Urotronic, Inc.
Sources (4)
- FDA 510(k) K191061 24 fields · synced Sep 18, 2026
- EUDAMED f35a98ed-a1ad-46fd-b163-5ef667212079 61 fields · synced Jul 10, 2026
- EUDAMED c1eec724-fee0-48d6-a74d-62b0a54e2b7a 61 fields · synced Jul 21, 2026
- EUDAMED 464f3040-ceaf-4e42-bd7c-75a9069c09c3 61 fields · synced Sep 18, 2026