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510(k) K813084

Device
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
Applicant
BURRON MEDICAL PRODUCTS, INC.
510(k) number
K813084
Product code
KOB  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-31
Date received
1981-11-02
Regulation
876.5090
Classification name
Catheter, Suprapubic (and Accessories)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KOB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.2024-11-01
K181097Cook Cystostomy Catheter SetCook Incorporated2019-01-18
K182709One-Step Suprapubic IntroducerCook Incorporated2018-12-26
K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated2018-10-30
K132890SUPRAPUBIC CATHETER AND INTRODUCER SETMediplus , Ltd.2014-01-17
K120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, Incorporated2012-10-26
K014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument Corp.2002-03-04
K012153LOWSLEY SUPRAPUBIC TRACTORCircon Video2001-09-19
K970969KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SETThe Kendal Co.1997-04-23
K970021RUSCH SUPRAPUBIC TRAYRusch, Inc.1997-02-07
K945480MOSS(R) STEEL BREAKAWAY(R) INTRODUCERHarry A. Schlakman1995-08-28
K953024LINDNER/GOLOMB SP INTRODUCING SOUNDCook Urological, Inc.1995-08-18
K952187RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILERusch, Inc.1995-07-25
K921071DENTOLOCKDentmed , Ltd.1992-03-26
K904798SUPRAPUBIC FLOW CONTROLLEROlympus Corp.1991-11-22

Legacy Summary#

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FDA Review#

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