FDA 510(k)

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set

K-Number: K181971 · 2019-04-23

Decision Date2019-04-23

Product CodeFAD

Advisory CommitteeGU

DecisionUnknown

Device Summary

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-04-23 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K181971.

When did Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07535580Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After UreteroscopyCOMPLETED NCT06045962Optimal Stent Duration After UreteroscopyACTIVE_NOT_RECRUITING NCT06979583Impact of Ureteral Stent and Sheaths Size on Post-Operative PainENROLLING_BY_INVITATION NCT07580963Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent LengthsNOT_YET_RECRUITING NCT07627828ComfiJ Versus Conventional Double-J Stent for Ureteral Stent SymptomsRECRUITING

Other records listing Cook Incorporated as applicant

PMA P020018SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT K233177Nest VT Vitrification Device K222254Gunther Tulip Vena Cava Filter Retrieval Set K223098Bakri Essential Postpartum Balloon K210734Endovascular Dilator and Sets K203670Extra Large Check-Flo Introducer

View all 147 devices →

Related Devices (Code: FAD)

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific Corporation K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

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.