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FDA 510(k)

PVC Hydrophilic Urethral Catheter

K-Number: K220722 · 2023-05-22

ApplicantWell Lead Medical Co., Ltd.
Decision Date2023-05-22
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PVC Hydrophilic Urethral Catheter is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-05-22 under approval number K220722. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVC Hydrophilic Urethral Catheter?

PVC Hydrophilic Urethral Catheter is a medical device that received FDA 510(k) clearance on 2023-05-22. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K220722.

When was PVC Hydrophilic Urethral Catheter approved by the FDA?

PVC Hydrophilic Urethral Catheter received FDA 510(k) clearance on 2023-05-22, under approval number K220722.

What company makes PVC Hydrophilic Urethral Catheter?

PVC Hydrophilic Urethral Catheter is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for PVC Hydrophilic Urethral Catheter?

The FDA product code for PVC Hydrophilic Urethral Catheter is EZD.

Related Clinical Trials

NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING NCT02761889 Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer COMPLETED NCT04035642 Single-Dose Image-Guided Radiotherapy With Urethral Sparing and DIL Boost for Intermediate-Risk Prostate Cancer (PROSINT II) RECRUITING

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Related Devices (Code: EZD)

K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc. K160858CompactCath Intermittent Urinary CatheterCompactcath, Inc. K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd. K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)Zhanjiang Star Enterprise Co., Ltd. K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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