pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

Q: What is the product code of K172289?

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

FDA 510(k) K172289 · Q Urological Corporation

Substantially Equivalent

510(k) numberK172289

Submission

Device name: pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
Applicant: Q Urological Corporation
Needham, MA, US
Received: July 31, 2017
Decision date: October 4, 2017
Decision: Substantially Equivalent (SESE)
Type: Special 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)	Device	Applicant	Decision
K251890	Disposable Ureteral StentsFAD · Traditional	Zhejiang Chuangxiang Medical Technology Co., Ltd.	02/20/2026SE
K251469	Endura Ureteral Stent and Stent SetFAD · Traditional	Cathegenix (Xiamen) Co., Ltd.	12/19/2025SESK
K243039	Ureteral Stents (AF-D series)FAD · Traditional	Alton (Shanghai) Medical Instruments Co., Ltd.	06/18/2025SE
K243830	Disposable ureteral stentFAD · Traditional	Shenzhen Trious Medical Technology Co., Ltd.	05/14/2025SE
K250824	Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special	Boston Scientific Corporation	04/15/2025SE
K232920	RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional	Ureteral Stent Company	03/22/2024SE
K211934	APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional	Boston Scientific Corporation	11/10/2022SESK
K213185	ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional	Coloplast Corp.	06/08/2022SESK
K213444	RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional	Ureteral Stent Company	03/17/2022SE
K213186	NovoFlow Reinforced Ureteral StentFAD · Traditional	Coloplast Corp.	02/16/2022SESK

More from Coloplast Corp.

510(k)	Device	Decision
K163068	pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentFAD · Special	12/22/2016SE
K082805	Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXXFAD · Traditional	01/20/2010SE

Questions and answers

When was pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent cleared by the FDA?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (K172289) received a 510(k) decision of Substantially Equivalent on October 4, 2017, 65 days after the submission was received.

What is the product code of K172289?

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