Product code EYB— Gastroenterology, Urology

FDA has cleared 28 devices under product code EYB between 1988 and 2020, filed by 21 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.

• 20201 clearance
• 20193 clearances
• 20182 clearances
• 20171 clearance
• 20141 clearance
• 20101 clearance
• 20091 clearance
• 20051 clearance
• 20041 clearance
• 20032 clearances
• 20022 clearances
• 19971 clearance
• 19961 clearance
• 19951 clearance
• 19944 clearances

• Cook Incorporated3 clearances
• Applied Medical Resources3 clearances
• Cook Urological, Inc.2 clearances
• Coloplast Corp.2 clearances
• C.R. Bard, Inc.2 clearances
• Surgitek1 clearance
• Promepal Sam1 clearance
• Porges S.A.1 clearance
• Medline Industries, Inc.1 clearance
• Mallinckroot, Inc.1 clearance

• K192183 — RocaTub Ureteral CatheterPromepal Sam·2020-04-23
• K191187 — Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.·2019-09-18
• K183323 — UPJ Occlusion Balloon CatheterCook Incorporated·2019-08-05
• K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook Incorporated·2019-06-17
• K182122 — Ureteric CathetersColoplast Corp.·2018-10-04
• K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated·2018-09-14
• K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersColoplast Corp.·2017-12-21
• K133750 — OCCLUDER OCCLUSION BALLOON CATHETERBoston Scientific Corporation·2014-01-08
• K092250 — MEDLINE RED RUBBER URETHRAL CATHETERMedline Industries, Inc.·2010-01-21
• K083788 — ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSREndooptiks, Inc.·2009-03-03
• K043581 — DUAL LUMEN CATHETERAcmi Corporation·2005-03-03
• K030293 — AMSURE RED RUBBER URETHRAL CATHETERAmsino International, Inc.·2004-02-04
• K033368 — FOSSA URETERAL OPEN LUMEN STENTFossa Medical, Inc.·2003-11-26
• K032521 — BARD DUAL LUMEN URETERAL CATHETERC.R. Bard, Inc.·2003-11-14
• K021856 — PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XXPorges S.A.·2002-10-17
• K020577 — APPLIED URETERAL CATHETERApplied Medical Resources Corp.·2002-05-22
• K964899 — KENDALL CURITY URETERAL CATHETERKendall Healthcare Products Co. Div.Of Tyco Health·1997-02-07
• K962004 — AQ HYDROPHILIC UROLOGICAL CATHETERSCook Urological, Inc.·1996-06-11
• K950300 — BARD FLEXIBLE TIP URETERAL CATHETERC.R. Bard, Inc.·1995-04-27
• K941011 — ACU-SIZER(TM)Applied Medical Resources·1994-06-13
• K941010 — ACUCISE GUIDEWIRE EXCHANGE SHEATHApplied Medical Resources·1994-04-18
• K941012 — LOW PRESSURE TAMPONADE BALLOON CATHETERApplied Medical Resources·1994-04-18
• K933020 — MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETERBoston Scientific Corp·1994-01-03
• K923729 — URETERAL CATHETERCook Urological, Inc.·1993-12-07
• K930483 — URETERAL CATHETERSurgitek·1993-07-16
• K921838 — ACUCISE URETERAL CUTTING CATHETERApplied Urology, Inc.·1993-02-26
• K914358 — ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIPHobbs Medical, Inc.·1991-11-19
• K882130 — FOLEY-TEMP(TM)Mallinckroot, Inc.·1988-08-09