FDA.reportPublic FDA data

Optilume Basic Urological Dilation catheter

Primary DI
00853095008365
Brand
Optilume Basic Urological Dilation catheter
Company
Urotronic, Inc.
Model
1147
Catalog number
1147-06030
Device 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.
Published
2025-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KOEDilator, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191061000Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.2020-01-02KOE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853095008365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853095008365008530950083658530950083650853095008365

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, single-useA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080558603
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859937006186Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit1235OPTBDL7008B2026-02-09
00859937006193Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit1235OPTBDL7009B2026-02-09
00859937006209Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit1235OPTBDL7010B2026-02-09
00859937006216Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit1235OPTBDL7011B2026-02-09
00859937006247Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7000B2026-02-09
00859937006254Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7001B2026-02-09
00859937006261Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7002B2026-02-09
00859937006278Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7003B2026-02-09
00859937006285Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7004B2026-02-09
00859937006292Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7005B2026-02-09
00859937006308Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7006B2026-02-09
00859937006315Optilume Urethral Drug Coated Balloon Catheter Kit1230OPTBDL7007B2026-02-09
00853095008341Optilume Basic Urological Dilation catheter11471147-080302025-07-18
00853095008358Optilume Basic Urological Dilation catheter11471147-080502025-07-18
00853095008372Optilume Basic Urological Dilation catheter11471147-060502025-07-18
00853095008389Optilume Basic Urological Dilation catheter11471147-100302025-07-18
00853095008396Optilume Basic Urological Dilation catheter11471147-100502025-07-18
00853095008129Optilume BPH Drug Coated Balloon Catheter11131113-300352023-08-05
00853095008150Optilume BPH Pre-dilation Catheter11371137-300352023-08-05
00853095008174Optilume BPH Drug Coated Balloon Catheter11131113-300402023-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2026-05-20
06976358503538SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503545SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503552SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503569SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503576SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503583SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
10840217910009Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
20840217910006Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00840217910002Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00853095008341Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008358Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008372Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008389Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008396Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
06936534328683Single Use Urethral DilatorZhejiang Chuangxiang Medical Technology Co., LTD.KOE2023-10-24
06936881102530Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136382Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136399Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136405Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136412Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136429Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136436Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136443Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136450Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12