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FDA 510(k)

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)

K-Number: K170233 · 2017-10-13

ApplicantZhanjiang Star Enterprise Co., Ltd.
Decision Date2017-10-13
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is a medical device manufactured by Zhanjiang Star Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2017-10-13 under approval number K170233. 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 Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is a medical device that received FDA 510(k) clearance on 2017-10-13. It is manufactured by Zhanjiang Star Enterprise Co., Ltd.. The 510(k) number is K170233.

When was Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) approved by the FDA?

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) received FDA 510(k) clearance on 2017-10-13, under approval number K170233.

What company makes Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is manufactured by Zhanjiang Star Enterprise Co., Ltd..

What is the FDA product code for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

The FDA product code for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary 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 NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED NCT05931887 Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention COMPLETED NCT05694793 Trial for Reliability of Urodynamics SysTem RECRUITING NCT07019623 U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. RECRUITING

Other Devices by Zhanjiang Star Enterprise Co., Ltd.

K170234Endotracheal tube; Reinforced Endotracheal tube

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. K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. K180738COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary CatheterCompactcath, Inc.

Official Source

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

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