FDA 510(k)

Sphincterotome / short-wire compatible, Sterile Sphincterotome

N.º K: K210934 · 2021-12-01

SolicitanteMicro-Tech (Nanjing) Co., Ltd.

Fecha de decisión2021-12-01

Código de productoKNS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sphincterotome / short-wire compatible, Sterile Sphincterotome 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 2021-12-01 under 510(k) number K210934. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sphincterotome / short-wire compatible, Sterile Sphincterotome?

Sphincterotome / short-wire compatible, Sterile Sphincterotome is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K210934.

When did Sphincterotome / short-wire compatible, Sterile Sphincterotome receive FDA 510(k) clearance?

Sphincterotome / short-wire compatible, Sterile Sphincterotome received FDA 510(k) clearance on 2021-12-01, under 510(k) number K210934.

Who is the listed applicant for Sphincterotome / short-wire compatible, Sterile Sphincterotome?

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 Sphincterotome / short-wire compatible, Sterile Sphincterotome?

The FDA product code for Sphincterotome / short-wire compatible, Sterile Sphincterotome is KNS.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Micro-Tech (Nanjing) Co., Ltd. como solicitante

K252492Visualized Access and Delivery Catheter; PB Digital Controller K251692Dispositivo de resección tisular avanzado 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 los 37 dispositivos →

Dispositivos relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.