Optilume Urethral Drug-Coated Balloon

FDA PMAFDA UDI

Class III (US FDA PMA)

PMA P210020

by Urotronic, Inc.

Identity

Trade Name: Optilume Urethral Drug Coated Balloon FDA PMAFDA UDI
Generic Name: Catheter, Balloon, Urethral, Drug-Coated FDA PMA
Urethral dilatation catheter, drug-eluting FDA UDI
Device Name: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use. FDA UDI
Model / Reference: 1110 FDA UDI
Description: The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use. FDA UDI

Identifiers

Catalog Number: 1110-10050B FDA UDI
Primary DI / UDI-DI: 00853095008310 FDA UDI
PMA Number: P210020 FDA PMAFDA UDI
FDA Product Code: QRH FDA PMAFDA UDI
GMDN Term: Urethral dilatation catheter, drug-eluting FDA UDI

Classification

Device Class: Class III FDA PMAFDA UDI
Advisory Committee: Gastroenterology, Urology FDA PMA
FDA Decision: APPR Approved FDA PMA
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Balloon Diameter — 10 Millimeter FDA UDI
Balloon Length — 50 Millimeter FDA UDI
Balloon Rated Burst Pressure — 10 Atmosphere FDA UDI

The Optilume Urethral Drug-Coated Balloon is a Catheter, Balloon, Urethral, Drug-Coated, classified as a Class III medical device. It is designed to treat obstructive urinary symptoms in adult males caused by anterior urethral strictures up to 3 cm in length by delivering localized drug therapy during dilation.

This device is intended for single-use in urological procedures and requires FDA Premarket Approval (PMA P210020). Sterility, sizing, and MRI safety are not specified in the regulatory submission. It is supplied as a sterile, disposable catheter and must be handled according to standard aseptic techniques prior to use.

Frequently asked questions

What is the Optilume Urethral Drug Coated Balloon used for?

The Optilume Urethral Drug Coated Balloon is designed to treat obstructive urinary symptoms in adult males caused by anterior urethral strictures up to 3 cm in length by delivering localized drug therapy during dilation.

Is the Optilume device reusable or single-use?

The Optilume Urethral Drug Coated Balloon is intended for single-use in urological procedures and must be handled according to standard aseptic techniques prior to use.

What sizes and models of the Optilume device are available?

The device data does not specify available sizes or models for the Optilume Urethral Drug Coated Balloon.

How is the Optilume device supplied?

The Optilume Urethral Drug Coated Balloon is supplied as a sterile, disposable catheter that must be handled according to standard aseptic techniques prior to use.

What is the regulatory status of the Optilume device?

The Optilume Urethral Drug Coated Balloon requires FDA Premarket Approval (PMA P210020) and has been approved for treating obstructive urinary symptoms associated with anterior urethral stricture in adult males.

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, Urotronic - Optilume

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P210020	Class III	Active

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Manufacturer

Manufacturer: Urotronic, Inc.

Sources (2)

FDA PMA P210020 24 fields · synced Sep 18, 2026
FDA UDI 3133c732-0297-45ac-a7a8-fe97b6183174 38 fields · synced May 27, 2026