All Silicone Supra-Pubia Catheter, Models 4880/4890

Q: What is the product code of K014002?

The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.

FDA 510(k) K014002 · Fortune Medical Instrument Corp.

Substantially Equivalent

510(k) numberK014002

Submission

Device name: All Silicone Supra-Pubia Catheter, Models 4880/4890
Applicant: Fortune Medical Instrument Corp.
Taipei Hsien, TW
Received: December 4, 2001
Decision date: March 4, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: KOB – Catheter, Suprapubic (And Accessories)
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5090
Specialty: Gastroenterology, Urology
Implant: Yes

Other 510(k)s with product code KOB

510(k)	Device	Applicant	Decision
K240514	AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional	Applied Medical Technology, Inc.	11/01/2024SE
K181097	Cook Cystostomy Catheter SetKOB · Traditional	Cook Incorporated	01/18/2019SESK
K182709	One-Step Suprapubic IntroducerKOB · Traditional	Cook Incorporated	12/26/2018SE
K182066	O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetKOB · Traditional	Cook Incorporated	10/30/2018SESK
K132890	Suprapubic Catheter and Introducer SetKOB · Traditional	Mediplus , Ltd.	01/17/2014SE
K120127	Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemKOB · Traditional	Swan Valley Medical, Incorporated	10/26/2012SE
K012153	Lowsley Suprapubic TractorKOB · Traditional	Circon Video	09/19/2001SE
K970969	Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional	The Kendal Co.	04/23/1997SE
K970021	Rusch Suprapubic TrayKOB · Traditional	Rusch, Inc.	02/07/1997SE
K945480	Moss(R) Steel Breakaway(R) IntroducerKOB · Traditional	Harry A. Schlakman	08/28/1995SE

More from Harry A. Schlakman

510(k)	Device	Decision
K022112	Fortune All Silicone Stomach (Gastric) Tubes, Model 2020KNT · Traditional	04/03/2003SE
K021193	Fortune Silicone Vacuum Suction, Model #1300HDB · Traditional	02/12/2003SE
K021142	All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865EZL · Traditional	10/01/2002SE
K980917	All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV ReservoirGCA · Traditional	05/27/1998SE
K980919	All Silicone 2-WAY & 3-WAY Foly Balloon Catheter and Nelaton CatheterEZL · Traditional	03/31/1998SE

Questions and answers

When was All Silicone Supra-Pubia Catheter, Models 4880/4890 cleared by the FDA?

All Silicone Supra-Pubia Catheter, Models 4880/4890 (K014002) received a 510(k) decision of Substantially Equivalent on March 4, 2002, 90 days after the submission was received.

What is the product code of K014002?

The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.