Product code KOB— Gastroenterology, Urology

FDA has cleared 32 devices under product code KOB between 1978 and 2024, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20241 clearance
• 20191 clearance
• 20182 clearances
• 20141 clearance
• 20121 clearance
• 20021 clearance
• 20011 clearance
• 19972 clearances
• 19953 clearances
• 19921 clearance
• 19912 clearances
• 19902 clearances
• 19883 clearances
• 19872 clearances
• 19862 clearances

• Cook Incorporated3 clearances
• Vance Products, Inc.2 clearances
• Van-Tec, Inc.2 clearances
• Rusch, Inc.2 clearances
• Cook Urological, Inc.2 clearances
• The Kendal Co.1 clearance
• Teledyne Getz1 clearance
• Swan Valley Medical, Incorporated1 clearance
• Porges Corp.1 clearance
• Phoenix Bioengineering, Inc.1 clearance

• K240514 — AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.·2024-11-01
• K181097 — Cook Cystostomy Catheter SetCook Incorporated·2019-01-18
• K182709 — One-Step Suprapubic IntroducerCook Incorporated·2018-12-26
• K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated·2018-10-30
• K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SETMediplus , Ltd.·2014-01-17
• K120127 — SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, Incorporated·2012-10-26
• K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument Corp.·2002-03-04
• K012153 — LOWSLEY SUPRAPUBIC TRACTORCircon Video·2001-09-19
• K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SETThe Kendal Co.·1997-04-23
• K970021 — RUSCH SUPRAPUBIC TRAYRusch, Inc.·1997-02-07
• K945480 — MOSS(R) STEEL BREAKAWAY(R) INTRODUCERHarry A. Schlakman·1995-08-28
• K953024 — LINDNER/GOLOMB SP INTRODUCING SOUNDCook Urological, Inc.·1995-08-18
• K952187 — RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILERusch, Inc.·1995-07-25
• K921071 — DENTOLOCKDentmed , Ltd.·1992-03-26
• K904798 — SUPRAPUBIC FLOW CONTROLLEROlympus Corp.·1991-11-22
• K904434 — SEXTON CYSTOTOMY URINE PUMP (SCUP2)Phoenix Bioengineering, Inc.·1991-02-01
• K901938 — SUPER STRENGTH DENTURE ADHESIVE CREAMTeledyne Getz·1990-06-06
• K901603 — MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETERBivona Medical Technologies·1990-05-04
• K884061 — ADD-A-CATHFemcare , Ltd.·1988-10-25
• K881097 — SPEC 5* SUPRAPUBIC CATHETERPorges Corp.·1988-06-03
• K874530 — URETHRAL DILATOR ENDOSCOPEAdvanced Surgical Intervention, Inc.·1988-01-27
• K870555 — VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SETVan-Tec, Inc.·1987-03-10
• K870556 — VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SETVan-Tec, Inc.·1987-03-10
• K863120 — (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SETCook Urological, Inc.·1986-10-24
• K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETSAngiomed U.S., Inc.·1986-10-24
• K852287 — PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SETCook Ob/Gyn·1985-08-08
• K852200 — SIMPLASTIC SUPRA PUBIC CATHETERFranklin Medical USA, Inc.·1985-08-07
• K843158 — SEXTON CYSTOTOMY URINE PUMPHolter-Hausner Intl.·1984-10-04
• K813084 — CYSTOFIX SUPRAPUBIC BLADDER DRAIN SETBurron Medical Products, Inc.·1981-12-31
• K810368 — VANCE PERCUTANEOUS MALECOT NEPHROSTOMYVance Products, Inc.·1981-03-20
• K800607 — SUPRAPUBIC TROCARG.D. Searle and Co.·1980-04-08
• K780765 — PERCUTANEOUS SURAPUBIC CATHETERVance Products, Inc.·1978-07-17