PRODEON MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3045323889	3045323889	PRODEON MEDICAL, INC.	1	N	2027-01-01	2200 Zanker Rd Ste F San Jose CA US 95131

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
349828	1527643868	K261342	Urocross Expander System (UES-2018-C1)	QKA	2026-06-22
349828	1312999910	K253525	Urocross Expander System (Model Numbers ES2018 and ES3025)	QKA	2026-03-12
349828	1653438238	K252572	Prodeon Urethral Sheath System	FED	2025-10-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
QKA	3	2026-06-22
FED	1	2025-10-07

GUDID#

Urocross Expander System - 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.
Prodeon Medical, Inc.
2026-10-15
Prodeon Urethral Sheath System - The Prodeon Urethral Sheath System is a sterile single-use, disposable device consisting of a Sheath and an Irrigation Valve.
Prodeon Medical, Inc.
2026-10-07