FDA 510(k) Applications for Medical Device Product Code "KOB"
(Catheter, Suprapubic (And Accessories))

FDA 510(k) Number Applicant Device Name Decision Date
K012153 CIRCON VIDEO LOWSLEY SUPRAPUBIC TRACTOR 09/19/2001
K181097 Cook Incorporated Cook Cystostomy Catheter Set 01/18/2019
K182066 Cook Incorporated O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set 10/30/2018
K182709 Cook Incorporated One-Step Suprapubic Introducer 12/26/2018
K014002 FORTUNE MEDICAL INSTRUMENT CORP. ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 03/04/2002
K132890 MEDIPLUS LTD. SUPRAPUBIC CATHETER AND INTRODUCER SET 01/17/2014
K970021 RUSCH, INC. RUSCH SUPRAPUBIC TRAY 02/07/1997
K120127 SWAN VALLEY MEDICAL, INCORPORATED SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM 10/26/2012
K970969 THE KENDAL CO. KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET 04/23/1997


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