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510(k) K240514

Device
AMT Low-Profile Suprapubic Catheter & Drainage Set
Applicant
Applied Medical Technology, Inc.
510(k) number
K240514
Product code
KOB
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-01
Date received
2024-02-22
Regulation
876.5090
Classification name
Catheter, Suprapubic (And Accessories)
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
Jennifer Hazou
Address
8006 Katherine Blvd. Brecksville OH US 44141 44141

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KOB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K904434SEXTON CYSTOTOMY URINE PUMP (SCUP2)Phoenix Bioengineering, Inc.1991-02-01