FDA.reportPublic FDA data

510(k) K241734

Device
Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
Applicant
Well Lead Medical Co., Ltd.
510(k) number
K241734
Product code
GBM
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-05
Date received
2024-06-17
Regulation
876.5130
Classification name
Catheter, Urethral
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

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 GBM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited2022-06-22
K211436Intermittent Catheter (Not Finalized)Hollister Incorporated2022-01-27
K200820SpeediCath Compact SetColoplast2020-11-13
K192904SpeediCath Compact SetColoplast2020-11-02
K200142SpeediCath SoftColoplast2020-07-30
K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd.2020-06-01
K191512LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc.2020-05-21
K192577Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc.2020-05-07
K193148VaPro Plus Pocket, VaPro PlusHollister Incorporated2019-12-13
K192468Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic CatheterHangzhou Bever Medical Devices Co., Ltd.2019-11-27
K191633Infyna ChicHollister Incorporated2019-07-19
K190620SpeediCath Flex Coude ProColoplast2019-07-10
K183335Medline Poly-Cath Red Polymer Urethral CatheterMedline Industries, Inc.2019-06-12
K183461Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent CatheterTeleflexmedical, Inc.2019-05-08
K182511SimplCathF&S Medical Solutions, LLC2019-03-20