KOBClass II

Catheter, Suprapubic (And Accessories)

21 CFR 876.5090 / Gastroenterology, Urology

KOB is the FDA product code for Catheter, Suprapubic (And Accessories), a class II device type, regulated under 21 CFR 876.5090. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 2024-11-01, and 66 recalls.

Classification record

Product code: KOB
Device name: Catheter, Suprapubic (And Accessories)
Regulation: 21 CFR 876.5090
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 32
Ingested recalls: 66

Clearances, product code KOB

By decision year

32 clearances under product code KOB with a decision year between 1978 and 2024, 1988 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code KOB by decision year
Year	Clearances
1978	1
1980	1
1981	2
1984	1
1985	2
1986	2
1987	2
1988	3
1990	2
1991	2
1992	1
1995	3
1997	2
2001	1
2002	1
2012	1
2014	1
2018	2
2019	1
2024	1

Applicants with the most clearances

Product code KOB

Applicants holding the most 510(k) clearances under product code KOB
Applicant	Clearances
Cook Incorporated	5
Rusch, Inc.	2
Van-Tec, Inc.	2
Vance Products, Inc.	2
Advanced Surgical Intervention, Inc.	1
Angiomed U.S., Inc.	1
Applied Medical Technology Inc	1
Bivona Medical Technologies	1
Burron Medical Products, Inc.	1
Circon Video	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order