Simplastic Supra Pubic Catheter

Q: What is the product code of K852200?

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) K852200 · Franklin Medical USA, Inc.

Substantially Equivalent

510(k) numberK852200

Submission

Device name: Simplastic Supra Pubic Catheter
Applicant: Franklin Medical USA, Inc.
Atlanta, GA, US
Received: May 21, 1985
Decision date: August 7, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K014002	All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional	Fortune Medical Instrument Corp.	03/04/2002SE
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

More from Rusch, Inc.

510(k)	Device	Decision
K931488	KSF Spinal Fixator · Traditional	01/21/1994SN
K884589	Frantz Medical Sharps CollectorFMF · Traditional	12/09/1988SE
K862478	Hayes Vaginal ShieldHDF · Traditional	11/24/1986SE

Questions and answers

When was Simplastic Supra Pubic Catheter cleared by the FDA?

Simplastic Supra Pubic Catheter (K852200) received a 510(k) decision of Substantially Equivalent on August 7, 1985, 78 days after the submission was received.

What is the product code of K852200?

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