FDA 510(k)

Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set

K-Number: K171603 · 2018-04-16

Decision Date2018-04-16

Product CodeFAD

Advisory CommitteeGU

DecisionUnknown

Device Summary

Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-04-16 under approval number K171603. 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 Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set?

Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set is a medical device that received FDA 510(k) clearance on 2018-04-16. It is manufactured by Cook Incorporated. The 510(k) number is K171603.

When was Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set approved by the FDA?

Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set received FDA 510(k) clearance on 2018-04-16, under approval number K171603.

What company makes Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set?

Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set is manufactured by Cook Incorporated.

What is the FDA product code for Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set?

The FDA product code for Cope Nephroureterostomy Stent and Amplatz 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.