Atlas FDA

EYB

28 FDA 510(k) clearances · Product code

102 daysmedian time to decision
315 days90th percentile
28clearances measured

FDA profile

Official device name
Catheter, Ureteral, Gastro-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2014: 9 · 2015: 9 · 2017: 10 · 2019: 22 · 2020: 13 · 2023: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RocaTub Ureteral Catheter (K192183)Promepal Sam2020-04-23
Dornier MINNOW Ureteral Catheter (K191187)Dornier Medtech America, Inc.2019-09-18
UPJ Occlusion Balloon Catheter (K183323)Cook Incorporated2019-08-05
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (K182695)Cook Incorporated2019-06-17
Ureteric Catheters (K182122)Coloplast Corp.2018-10-04
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter (K180182)Cook Incorporated2018-09-14
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (K171043)Coloplast Corp.2017-12-21
OCCLUDER OCCLUSION BALLOON CATHETER (K133750)Boston Scientific Corporation2014-01-08
MEDLINE RED RUBBER URETHRAL CATHETER (K092250)Medline Industries, Inc.2010-01-21
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (K083788)Endooptiks, Inc.2009-03-03
DUAL LUMEN CATHETER (K043581)Acmi Corporation2005-03-03
AMSURE RED RUBBER URETHRAL CATHETER (K030293)Amsino International, Inc.2004-02-04
FOSSA URETERAL OPEN LUMEN STENT (K033368)Fossa Medical, Inc.2003-11-26
BARD DUAL LUMEN URETERAL CATHETER (K032521)C.R. Bard, Inc.2003-11-14
PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX (K021856)Porges S.A.2002-10-17
APPLIED URETERAL CATHETER (K020577)Applied Medical Resources Corp.2002-05-22
KENDALL CURITY URETERAL CATHETER (K964899)Kendall Healthcare Products Co. Div.Of Tyco Health1997-02-07
AQ HYDROPHILIC UROLOGICAL CATHETERS (K962004)Cook Urological, Inc.1996-06-11
BARD FLEXIBLE TIP URETERAL CATHETER (K950300)C.R. Bard, Inc.1995-04-27
ACU-SIZER(TM) (K941011)Applied Medical Resources1994-06-13
ACUCISE GUIDEWIRE EXCHANGE SHEATH (K941010)Applied Medical Resources1994-04-18
LOW PRESSURE TAMPONADE BALLOON CATHETER (K941012)Applied Medical Resources1994-04-18
MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER (K933020)Boston Scientific Corp1994-01-03
URETERAL CATHETER (K923729)Cook Urological, Inc.1993-12-07
URETERAL CATHETER (K930483)Surgitek1993-07-16
ACUCISE URETERAL CUTTING CATHETER (K921838)Applied Urology, Inc.1993-02-26
ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP (K914358)Hobbs Medical, Inc.1991-11-19
FOLEY-TEMP(TM) (K882130)Mallinckroot, Inc.1988-08-09

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