Urosurge Urostent

FDA 510(k) K973504 · Princeton Regulatory Assoc.

Substantially Equivalent

510(k) numberK973504

Submission

Device name
Urosurge Urostent
Applicant
Princeton Regulatory Assoc.
Princeton, NJ, US
Received
September 16, 1997
Decision date
January 30, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FAD – Stent, Ureteral
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4620
Specialty
Gastroenterology, Urology
Implant
Yes

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K251469Endura™ Ureteral Stent and Stent SetFAD · Traditional Cathegenix (Xiamen) Co., Ltd.12/19/2025SESK
K243039Ureteral Stents (AF-D series)FAD · Traditional Alton (Shanghai) Medical Instruments Co., Ltd.06/18/2025SE
K243830Disposable ureteral stentFAD · Traditional Shenzhen Trious Medical Technology Co., Ltd.05/14/2025SE
K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special Boston Scientific Corporation04/15/2025SE
K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit…FAD · Traditional Ureteral Stent Company03/22/2024SE
K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional Boston Scientific Corporation11/10/2022SESK
K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional Coloplast Corp.06/08/2022SESK
K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional Ureteral Stent Company03/17/2022SE
K213186NovoFlow Reinforced Ureteral StentFAD · Traditional Coloplast Corp.02/16/2022SESK

More from Coloplast Corp.

510(k)DeviceDecision
K965136Urosurge Urotherm Fluid Warming SystemLHC · Traditional 10/16/1998SE
K972158Go Medical Patient Controlled Analgesia DevicesMEB · Traditional 02/20/1998SE
K962770Urosurge AcutrainerKPN · Traditional 08/01/1996SE

Questions and answers

When was Urosurge Urostent cleared by the FDA?

Urosurge Urostent (K973504) received a 510(k) decision of Substantially Equivalent on January 30, 1998, 136 days after the submission was received.

What is the product code of K973504?

The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.