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FDA 510(k)

Vortek Single Loop Ureteral Stent

K-Number: K201436 · 2021-02-25

ApplicantColoplast Corp.
Decision Date2021-02-25
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vortek Single Loop Ureteral Stent is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2021-02-25 under approval number K201436. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vortek Single Loop Ureteral Stent?

Vortek Single Loop Ureteral Stent is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Coloplast Corp.. The 510(k) number is K201436.

When was Vortek Single Loop Ureteral Stent approved by the FDA?

Vortek Single Loop Ureteral Stent received FDA 510(k) clearance on 2021-02-25, under approval number K201436.

What company makes Vortek Single Loop Ureteral Stent?

Vortek Single Loop Ureteral Stent is manufactured by Coloplast Corp..

What is the FDA product code for Vortek Single Loop Ureteral Stent?

The FDA product code for Vortek Single Loop Ureteral Stent is FAD.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT06710938 Thoracoabdominal Artery Stent Graft System Exploratory Study RECRUITING NCT07587099 Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I) RECRUITING NCT07538609 The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study NOT_YET_RECRUITING NCT07580963 Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths NOT_YET_RECRUITING NCT05650411 Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM) RECRUITING

Other Devices by Coloplast Corp.

K161672SpeediCath Flex Coude K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators K182831SabreLine and SabreGuard Laser Fibers

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Related Devices (Code: FAD)

K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation K161277ConvertX Nephroureteral Stent SystemBrightwater Medical K160891Ultrathane Endoureterotomy Stent SetCook Incorporated K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSColoplast Corp. K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp.

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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