FDA.reportPublic FDA data

510(k) K220036

Device
Wellead Ureteral Catheter
Applicant
Well Lead Medical Co., Ltd.
510(k) number
K220036
Product code
KOD
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-16
Date received
2022-01-05
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
Jenny Zhu
Address
# 47, Guomao Ave. S., Hualong, Panyu Guangzhou CN 511434 511434

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
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
K110491BACKSTOP CATHETERPluromed, Inc.2011-03-16