Urocross Expander System

Primary DI
00860013645113
Brand
Urocross Expander System
Company
Prodeon Medical, Inc.
Model
UES-2018-C1
Catalog number
UES-2018-C1
Device description
The Urocross Expander System comprises the Urocross Expander Implant which is preloaded in a constrained configuration within the distal section of the Delivery Catheter and is tethered to Delivery Catheter for controlled release. The handle/plunger of the Delivery Catheter controls advancement, deployment, and release of the implant. To provide an access port for the Delivery Catheter and irrigation to the cystsocsope, the Urocross Expander System includes an Irrigation Connector which attaches to the female luer on the cystoscope. Pressurized irrigation line is attached to the Irrigation Connector valve enabling clearing of the visual field within the prostatic urethra.
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic HyperplasiaGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261342000Urocross Expander System (UES-2018-C1)Prodeon Medical, Inc.2026-06-22QKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013645113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013645113008600136451138600136451130860013645113

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal urethral stent, long-termA non-bioabsorbable tubular or ring-like device intended to be implanted indefinitely/long-term in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve obstructions from bulbar urethral strictures, benign prostatic hyperplasia (BPH), and/or detrusor external sphincter dyssynergia (DESD). It is made entirely of metal (e.g., Nitinol) and may be meshed to facilitate embedding in the surrounding tissue. It may be inserted with a balloon catheter or may self-expand in situ; disposable devices (non-powered or electronic) dedicated to implantation may be included with the stent.

Regulatory Flags#

DUNS number
111233815
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013645120Prodeon Urethral Sheath SystemPUS1832PUS18322026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290015518192iTind Removal KitMEDI-TATE LTDQKA2023-10-25
17290015518083Snare X5MEDI-TATE LTDQKA2021-07-20
07290015518062iTIND SystemMEDI-TATE LTDQKA2020-11-10
07290015518079iTINDMEDI-TATE LTDQKA2020-11-10
07290015518086SNAREMEDI-TATE LTDQKA2020-11-10
07290015518109iTIND SystemMEDI-TATE LTDQKA2020-11-10