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FDA 510(k)

BIOSOFT DUO DOUBLE LOOP URETERAL STENTS

K-Number: K170422 · 2017-11-02

ApplicantColoplast Corp.
Decision Date2017-11-02
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOSOFT DUO DOUBLE LOOP URETERAL STENTS is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2017-11-02 under approval number K170422. 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 BIOSOFT DUO DOUBLE LOOP URETERAL STENTS?

BIOSOFT DUO DOUBLE LOOP URETERAL STENTS is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by Coloplast Corp.. The 510(k) number is K170422.

When was BIOSOFT DUO DOUBLE LOOP URETERAL STENTS approved by the FDA?

BIOSOFT DUO DOUBLE LOOP URETERAL STENTS received FDA 510(k) clearance on 2017-11-02, under approval number K170422.

What company makes BIOSOFT DUO DOUBLE LOOP URETERAL STENTS?

BIOSOFT DUO DOUBLE LOOP URETERAL STENTS is manufactured by Coloplast Corp..

What is the FDA product code for BIOSOFT DUO DOUBLE LOOP URETERAL STENTS?

The FDA product code for BIOSOFT DUO DOUBLE LOOP URETERAL STENTS 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 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 K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators K182831SabreLine and SabreGuard Laser Fibers K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

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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. K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation

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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