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FDA 510(k)

Sof-Flex Ureteral Stent Set

K-Number: K180053 · 2018-09-13

ApplicantCook Incorporated
Decision Date2018-09-13
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Sof-Flex Ureteral Stent Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-09-13 under approval number K180053. 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 Sof-Flex Ureteral Stent Set?

Sof-Flex Ureteral Stent Set is a medical device that received FDA 510(k) clearance on 2018-09-13. It is manufactured by Cook Incorporated. The 510(k) number is K180053.

When was Sof-Flex Ureteral Stent Set approved by the FDA?

Sof-Flex Ureteral Stent Set received FDA 510(k) clearance on 2018-09-13, under approval number K180053.

What company makes Sof-Flex Ureteral Stent Set?

Sof-Flex Ureteral Stent Set is manufactured by Cook Incorporated.

What is the FDA product code for Sof-Flex Ureteral Stent Set?

The FDA product code for Sof-Flex Ureteral Stent Set 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 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

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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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