Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

Q: What is the product code of K211032?

The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.

FDA 510(k) K211032 · Urogen Pharma, Ltd.

Substantially Equivalent

510(k) numberK211032

Submission

Device name: Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
Applicant: Urogen Pharma, Ltd.
Ra'Anana, IL
Received: April 7, 2021
Decision date: November 19, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KOD – Catheter, Urological
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5130
Specialty: Gastroenterology, Urology

Other 510(k)s with product code KOD

510(k)	Device	Applicant	Decision
K251864	Rubber Utility CatheterKOD · Traditional	C.R. Bard, Inc.	02/23/2026SE
K220036	Wellead Ureteral CatheterKOD · Traditional	Well Lead Medical Co., Ltd.	12/16/2022SE
K220730	allFlex Ureteral Catheters, Krait Ureteral CathetersKOD · Traditional	Allwin Medical Devices, Inc.	10/13/2022SE
K181979	Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional	Teleflexmedical, Inc.	05/24/2019SE
K180354	UroGen Ureteral CatheterKOD · Traditional	Urogen Pharma, Ltd.	10/30/2018SE
K181144	Angled Tip Ureteral CatheterKOD · Traditional	Cook Incorporated	06/28/2018SE
K180530	Imager II Urology Torque CatheterKOD · Special	Boston Scientific Corporation	04/10/2018SE
K171810	Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional	Cook Incorporated	03/07/2018SE
K171600	Renal Access Cobra Catheter, Kumpe Access CatheterKOD · Traditional	Cook Incorporated	02/16/2018SE
K171662	Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End…KOD · Traditional	Cook Incorporated	02/01/2018SE

More from Cook Incorporated

510(k)	Device	Decision
K203321	Cystoject Syringe LeverQBL · Special	12/09/2020SE
K190987	Uroject12 Syringe LeverQBL · Special	12/02/2019SE
K180354	UroGen Ureteral CatheterKOD · Traditional	10/30/2018SE
K180345	Uroject12 Syringe LeverQBL · Traditional	10/17/2018SE

Questions and answers

When was Urinary Catheter 12 Fr, Urinary Catheter 16 Fr cleared by the FDA?

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (K211032) received a 510(k) decision of Substantially Equivalent on November 19, 2021, 226 days after the submission was received.

What is the product code of K211032?

The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.