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FDA 510(k)

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set

K-Number: K181971 · 2019-04-23

ApplicantCook Incorporated
Decision Date2019-04-23
Product CodeFAD
Advisory CommitteeGU
DecisionUnknown

Device Summary

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-04-23 under approval number K181971. 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 Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set?

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set is a medical device that received FDA 510(k) clearance on 2019-04-23. It is manufactured by Cook Incorporated. The 510(k) number is K181971.

When was Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set approved by the FDA?

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set received FDA 510(k) clearance on 2019-04-23, under approval number K181971.

What company makes Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set?

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set is manufactured by Cook Incorporated.

What is the FDA product code for Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set?

The FDA product code for Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy 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 NCT06547632 ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach TERMINATED NCT07072598 Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS 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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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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