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FDA 510(k)

VORTEK URETERAL DOUBLE LOOP STENT

K-Number: K180057 · 2018-03-09

ApplicantColoplast Corp.
Decision Date2018-03-09
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VORTEK URETERAL DOUBLE LOOP STENT is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2018-03-09 under approval number K180057. 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 URETERAL DOUBLE LOOP STENT?

VORTEK URETERAL DOUBLE LOOP STENT is a medical device that received FDA 510(k) clearance on 2018-03-09. It is manufactured by Coloplast Corp.. The 510(k) number is K180057.

When was VORTEK URETERAL DOUBLE LOOP STENT approved by the FDA?

VORTEK URETERAL DOUBLE LOOP STENT received FDA 510(k) clearance on 2018-03-09, under approval number K180057.

What company makes VORTEK URETERAL DOUBLE LOOP STENT?

VORTEK URETERAL DOUBLE LOOP STENT is manufactured by Coloplast Corp..

What is the FDA product code for VORTEK URETERAL DOUBLE LOOP STENT?

The FDA product code for VORTEK URETERAL DOUBLE LOOP STENT is FAD.

Related Clinical Trials

NCT07580963 Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths NOT_YET_RECRUITING NCT06375967 EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) SUSPENDED NCT06719089 Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent RECRUITING NCT06045962 Optimal Stent Duration After Ureteroscopy ACTIVE_NOT_RECRUITING NCT07535580 Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After Ureteroscopy COMPLETED

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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