Atlas FDA

KOB

32 FDA 510(k) clearances · Product code

71 daysmedian time to decision
267 days90th percentile
32clearances measured

FDA profile

Official device name
Catheter, Suprapubic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5090
Medical specialty
Gastroenterology, Urology
Flags
Implant
Adverse events (MAUDE)
2007: 2 · 2008: 6 · 2009: 4 · 2011: 12 · 2017: 12 · 2018: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AMT Low-Profile Suprapubic Catheter & Drainage Set (K240514)Applied Medical Technology, Inc.2024-11-01
Cook Cystostomy Catheter Set (K181097)Cook Incorporated2019-01-18
One-Step Suprapubic Introducer (K182709)Cook Incorporated2018-12-26
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (K182066)Cook Incorporated2018-10-30
SUPRAPUBIC CATHETER AND INTRODUCER SET (K132890)Mediplus , Ltd.2014-01-17
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM (K120127)Swan Valley Medical, Incorporated2012-10-26
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (K014002)Fortune Medical Instrument Corp.2002-03-04
LOWSLEY SUPRAPUBIC TRACTOR (K012153)Circon Video2001-09-19
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (K970969)The Kendal Co.1997-04-23
RUSCH SUPRAPUBIC TRAY (K970021)Rusch, Inc.1997-02-07
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (K945480)Harry A. Schlakman1995-08-28
LINDNER/GOLOMB SP INTRODUCING SOUND (K953024)Cook Urological, Inc.1995-08-18
RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE (K952187)Rusch, Inc.1995-07-25
DENTOLOCK (K921071)Dentmed , Ltd.1992-03-26
SUPRAPUBIC FLOW CONTROLLER (K904798)Olympus Corp.1991-11-22
SEXTON CYSTOTOMY URINE PUMP (SCUP2) (K904434)Phoenix Bioengineering, Inc.1991-02-01
SUPER STRENGTH DENTURE ADHESIVE CREAM (K901938)Teledyne Getz1990-06-06
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER (K901603)Bivona Medical Technologies1990-05-04
ADD-A-CATH (K884061)Femcare , Ltd.1988-10-25
SPEC 5* SUPRAPUBIC CATHETER (K881097)Porges Corp.1988-06-03
URETHRAL DILATOR ENDOSCOPE (K874530)Advanced Surgical Intervention, Inc.1988-01-27
VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET (K870556)Van-Tec, Inc.1987-03-10
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET (K870555)Van-Tec, Inc.1987-03-10
VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS (K863386)Angiomed U.S., Inc.1986-10-24
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET (K863120)Cook Urological, Inc.1986-10-24
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET (K852287)Cook Ob/Gyn1985-08-08
SIMPLASTIC SUPRA PUBIC CATHETER (K852200)Franklin Medical USA, Inc.1985-08-07
SEXTON CYSTOTOMY URINE PUMP (K843158)Holter-Hausner Intl.1984-10-04
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET (K813084)Burron Medical Products, Inc.1981-12-31
VANCE PERCUTANEOUS MALECOT NEPHROSTOMY (K810368)Vance Products, Inc.1981-03-20
SUPRAPUBIC TROCAR (K800607)G.D. Searle and Co.1980-04-08
PERCUTANEOUS SURAPUBIC CATHETER (K780765)Vance Products, Inc.1978-07-17

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Every clearance here is in the API, with alerts when new ones post.