Self-Cath CS Closed Urinary Catheterization System

Q: What is the product code of K070939?

The FDA product code is FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), a Class II (moderate risk) device regulated under 21 CFR 876.5130.

FDA 510(k) K070939 · Coloplast Manufacturing Us, LLC

Substantially Equivalent

510(k) numberK070939

Submission

Device name: Self-Cath CS Closed Urinary Catheterization System
Applicant: Coloplast Manufacturing Us, LLC
Minneapolis, MN, US
Received: April 4, 2007
Decision date: June 1, 2007
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5130
Specialty: Gastroenterology, Urology

Other 510(k)s with product code FCM

510(k)	Device	Applicant	Decision
K254076	BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional	C.R. Bard, Inc.	05/29/2026SESK
K250891	Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter…FCM · Special	Convatec Limited	06/06/2025SESK
K223821	Self-Cath Closed SystemFCM · Traditional	Coloplast	08/02/2023SE
K082831	Amself Closed Catheterization SystemFCM · Special	Amsino International, Inc.	10/23/2008SE
K070048	Guardian Catheter-Infant Urinary Collection KitFCM · Traditional	Marian Medical, Inc.	03/15/2007SE
K030712	Amsure Urethral Catheterization TrayFCM · Traditional	Amsino International, Inc.	05/23/2003SE
K030664	Amsure Foley Insertion TrayFCM · Traditional	Amsino International, Inc.	05/23/2003SE
K011055	The O'Neil Sterile Field Urinary Catheter Kit with Prep PadsFCM · Traditional	Go Medical Industries Pty. , Ltd.	06/06/2001SE
K010420	Rusch Mmg/O'Neil CatheterFCM · Traditional	Rusch, Inc.	05/09/2001SE
K003873	Mentor Self-Cath Closed SystemFCM · Traditional	Mentor Corp.	03/29/2001SE

More from Mentor Corp.

510(k)	Device	Decision
K100878	Self Cath CatheterEZD · Traditional	05/26/2010SE
K093112	Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model…GAW · Traditional	02/01/2010SE
K082640	Virtue Ventral Urethral Elevation Sling SystemOTM · Traditional	10/17/2008SE

Questions and answers

When was Self-Cath CS Closed Urinary Catheterization System cleared by the FDA?

Self-Cath CS Closed Urinary Catheterization System (K070939) received a 510(k) decision of Substantially Equivalent on June 1, 2007, 58 days after the submission was received.

What is the product code of K070939?

The FDA product code is FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), a Class II (moderate risk) device regulated under 21 CFR 876.5130.