FDA 510(k)

Universa Soft Ureteral Stents and Stent Sets

Número K: K151051 · 2016-01-11

Data da decisão2016-01-11

Código do produtoFAD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Universa Soft Ureteral Stents and Stent Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-01-11 under 510(k) number K151051. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Universa Soft Ureteral Stents and Stent Sets?

Universa Soft Ureteral Stents and Stent Sets is a medical device that received FDA 510(k) clearance on 2016-01-11. The listed applicant is Cook Incorporated. The 510(k) number is K151051.

When did Universa Soft Ureteral Stents and Stent Sets receive FDA 510(k) clearance?

Universa Soft Ureteral Stents and Stent Sets received FDA 510(k) clearance on 2016-01-11, under 510(k) number K151051.

Who is the listed applicant for Universa Soft Ureteral Stents and Stent Sets?

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 Universa Soft Ureteral Stents and Stent Sets?

The FDA product code for Universa Soft Ureteral Stents and Stent Sets is FAD.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Cook Incorporated como candidato(a)

K233177Nest VT Vitrification Device K222254Gunther Tulip Vena Cava Filter Retrieval Set K223098Bakri Essential Postpartum Balloon K210734Endovascular Dilator and Sets K203670Extra Large Check-Flo Introducer K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc

Ver todos os 146 dispositivos →

Dispositivos Relacionados (Código: 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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.