FDA.report

510(k) K220722

Device
PVC Hydrophilic Urethral Catheter
Applicant
Well Lead Medical Co., Ltd.
510(k) number
K220722
Product code
EZD
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-22
Date received
2022-03-14
Regulation
876.5130
Classification name
Catheter, Straight
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

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

Related GUDID Devices

Primary DIBrandCompanyPublished
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20197344162052MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162069MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162076MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
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20197344162137MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162144MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
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20197344162182MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162199MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162205MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162212MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162229MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162236MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162243MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162250MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162267MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162274MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
20197344162021MEDLINEMEDLINE INDUSTRIES, INC.2025-09-22
06936881163449Wellead PVC Hydrophilic Urethral CatheterWell Lead Medical Co.,Ltd2023-11-06
16936881163507Wellead PVC Hydrophilic Urethral CatheterWell Lead Medical Co.,Ltd2023-11-06
16936881163514Wellead PVC Hydrophilic Urethral CatheterWell Lead Medical Co.,Ltd2023-11-06
16936881163521Wellead PVC Hydrophilic Urethral CatheterWell Lead Medical Co.,Ltd2023-11-06
16936881163538Wellead PVC Hydrophilic Urethral CatheterWell Lead Medical Co.,Ltd2023-11-06
16936881163545Wellead PVC Hydrophilic Urethral CatheterWell Lead Medical Co.,Ltd2023-11-06
16936881163552Wellead PVC Hydrophilic Urethral CatheterWell Lead Medical Co.,Ltd2023-11-06
16936881163569Wellead PVC Hydrophilic Urethral CatheterWell Lead Medical Co.,Ltd2023-11-06

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