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510(k) K192183

Device
RocaTub Ureteral Catheter
Applicant
Promepal Sam
510(k) number
K192183
Product code
EYB  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-23
Date received
2019-08-12
Regulation
876.5130
Classification name
Catheter, Ureteral, Gastro-urology
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mohamed Rekik
Address
9 Ave. Albert Ii Monaco MC 98000 98000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EYB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.2019-09-18
K183323UPJ Occlusion Balloon CatheterCook Incorporated2019-08-05
K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook Incorporated2019-06-17
K182122Ureteric CathetersColoplast Corp.2018-10-04
K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated2018-09-14
K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersColoplast Corp.2017-12-21
K133750OCCLUDER OCCLUSION BALLOON CATHETERBoston Scientific Corporation2014-01-08
K092250MEDLINE RED RUBBER URETHRAL CATHETERMedline Industries, Inc.2010-01-21
K083788ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSREndooptiks, Inc.2009-03-03
K043581DUAL LUMEN CATHETERAcmi Corporation2005-03-03
K030293AMSURE RED RUBBER URETHRAL CATHETERAmsino International, Inc.2004-02-04
K033368FOSSA URETERAL OPEN LUMEN STENTFossa Medical, Inc.2003-11-26
K032521BARD DUAL LUMEN URETERAL CATHETERC.R. Bard, Inc.2003-11-14
K021856PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XXPorges S.A.2002-10-17
K020577APPLIED URETERAL CATHETERApplied Medical Resources Corp.2002-05-22

Legacy Summary#

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FDA Review#

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