RocaJJ Soft Stents

FDA 510(k) K173734 · Promepla Sam

Substantially Equivalent

510(k) numberK173734

Submission

Device name
RocaJJ Soft Stents
Applicant
Promepla Sam
Monaco, MC
Received
December 6, 2017
Decision date
March 12, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

Other 510(k)s with product code FAD

510(k)DeviceApplicantDecision
K251890Disposable Ureteral StentsFAD · Traditional Zhejiang Chuangxiang Medical Technology Co., Ltd.02/20/2026SE
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
K182144Bi-Flex EvoKNY · Special 09/07/2018SE
K152278ENDOFLOW II - Irrigation, Warming and Suction SystemOCX · Traditional 02/09/2016SE
K140441Bi-Flex Ureteral Access SheathKNY · Traditional 06/17/2014SE
K120160Rocamed Rocaus PlatinumKNY · Traditional 05/14/2012SE

Questions and answers

When was RocaJJ Soft Stents cleared by the FDA?

RocaJJ Soft Stents (K173734) received a 510(k) decision of Substantially Equivalent on March 12, 2018, 96 days after the submission was received.

What is the product code of K173734?

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