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510(k) K080878

Device
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
Applicant
MEDICAL TECHNOLOGIES OF GEORGIA, INC.
510(k) number
K080878
Product code
KOD  
Decision
Substantially Equivalent (SESE)
Decision date
2008-07-17
Date received
2008-03-31
Regulation
876.5130
Classification name
Catheter, Urological
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
CINDI SARTAIN
Address
15151 Prater Dr. Suite E Covington GA US 30014 30014

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KOD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251864Rubber Utility CatheterC.R. Bard, Inc.2026-02-23
K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.2022-12-16
K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.2022-10-13
K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.2021-11-19
K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.2019-05-24
K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.2018-10-30
K181144Angled Tip Ureteral CatheterCook Incorporated2018-06-28
K180530Imager II Urology Torque CatheterBoston Scientific Corporation2018-04-10
K171810Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterCook Incorporated2018-03-07
K171600Renal Access Cobra Catheter, Kumpe Access CatheterCook Incorporated2018-02-16
K171662Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral CatheterCook Incorporated2018-02-01
K172924GentleCath Intermittent Urinary CatheterConvatec Limited2017-11-21
K161344GentleCath Glide Intermittent CatheterConvatec Limited2016-09-20
K160877United Urologics Closed System CatheterRobling Medical, Inc.2016-05-20
K140953GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETERConvatec, Ltd.2014-08-01

Legacy Summary#

summary

FDA Review#

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