FDA 510(k)

Single-use Video Pancreaticobiliary Scope, PB Digital Controller

Número K: K221784 · 2023-02-16

RequerenteMicro-Tech (Nanjing) Co., Ltd.

Data da decisão2023-02-16

Código do produtoFBN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single-use Video Pancreaticobiliary Scope, PB Digital Controller is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K221784. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

Single-use Video Pancreaticobiliary Scope, PB Digital Controller is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K221784.

When did Single-use Video Pancreaticobiliary Scope, PB Digital Controller receive FDA 510(k) clearance?

Single-use Video Pancreaticobiliary Scope, PB Digital Controller received FDA 510(k) clearance on 2023-02-16, under 510(k) number K221784.

Who is the listed applicant for Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

The FDA product code for Single-use Video Pancreaticobiliary Scope, PB Digital Controller is FBN.

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 Micro-Tech (Nanjing) Co., Ltd. como candidato(a)

K252492Visualized Access and Delivery Catheter; PB Digital Controller K251692Dispositivo de Resseção de Tecido Avançado K250229Dual Action Tissue Closure Device K243388Disposable Distal Cap K243471Extraction Basket K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible

Ver todos os 37 dispositivos →

Dispositivos Relacionados (Código: FBN)

K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)Scivita Medical Technology Co., Ltd.K251170Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLC K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.

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.