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FDA 510(k)

C-Flex Ureteral Stent Set

K-Number: K162104 · 2017-04-24

ApplicantCook Incorporated
Decision Date2017-04-24
Product CodeFAD
Advisory CommitteeGU
DecisionUnknown

Device Summary

C-Flex Ureteral Stent Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-04-24 under approval number K162104. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the C-Flex Ureteral Stent Set?

C-Flex Ureteral Stent Set is a medical device that received FDA 510(k) clearance on 2017-04-24. It is manufactured by Cook Incorporated. The 510(k) number is K162104.

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

C-Flex Ureteral Stent Set received FDA 510(k) clearance on 2017-04-24, under approval number K162104.

What company makes C-Flex Ureteral Stent Set?

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

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

The FDA product code for C-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)

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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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