PSM 3-Way Silicone Foley Catheter

Q: What is the product code of K181616?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.

FDA 510(k) K181616 · Pathway, LLC

Substantially Equivalent

510(k) numberK181616

Submission

Device name: PSM 3-Way Silicone Foley Catheter
Applicant: Pathway, LLC
Santee, CA, US
Received: June 19, 2018
Decision date: September 21, 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: EZL – Catheter, Retention Type, Balloon
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5130
Specialty: Gastroenterology, Urology

Other 510(k)s with product code EZL

510(k)	Device	Applicant	Decision
K260756	TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional	Sentinel Medical Technologies,	09/04/2026SE
K262056	Rusch Latex Gold Foley CatheterEZL · Traditional	Teleflex Medical Sdn. Bhd.	08/05/2026SE
K252537	Rusch SoftSimplastic Foley CathetersEZL · Traditional	Teleflex Medical Sdn. Bhd.	01/20/2026SE
K243011	Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional	Guangdong Ecan Medical Co., Ltd.	06/16/2025SE
K241424	InnoCare Specialty Foley CatheterEZL · Traditional	Innocare Urologics, LLC	09/18/2024SE
K232469	Rüsch Latex Gold Foley CatheterEZL · Traditional	Teleflexmedical, Inc.	08/01/2024SE
K240057	TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional	Sentinel Medical Technologies, LLC	04/17/2024SE
K233411	Folysil Silicone CatheterEZL · Traditional	Coloplast Corp.	04/15/2024SE
K233013	2-Way 100% Silicone Cleartract CatheterEZL · Traditional	Silq Technologies Corporation	01/23/2024SE
K212077	Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional	Teleflexmedical, Inc.	07/27/2023SE

More from Teleflexmedical, Inc.

510(k)	Device	Decision
K192034	HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley…EZL · Traditional	04/21/2020SE
K162233	Kurin Blood Culture Collection SetJKA · Traditional	12/23/2016SE

Questions and answers

When was PSM 3-Way Silicone Foley Catheter cleared by the FDA?

PSM 3-Way Silicone Foley Catheter (K181616) received a 510(k) decision of Substantially Equivalent on September 21, 2018, 94 days after the submission was received.

What is the product code of K181616?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.