FDA 510(k)

Promisemed VeriEcto Automatic Biopsy Needles

Número K: K261196 · 2026-05-12

RequerentePromisemed Hangzhou Meditech Co., Ltd.

Data da decisão2026-05-12

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Promisemed VeriEcto Automatic Biopsy Needles is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K261196. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Promisemed VeriEcto Automatic Biopsy Needles?

Promisemed VeriEcto Automatic Biopsy Needles is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K261196.

When did Promisemed VeriEcto Automatic Biopsy Needles receive FDA 510(k) clearance?

Promisemed VeriEcto Automatic Biopsy Needles received FDA 510(k) clearance on 2026-05-12, under 510(k) number K261196.

Who is the listed applicant for Promisemed VeriEcto Automatic Biopsy Needles?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Promisemed VeriEcto Automatic Biopsy Needles?

The FDA product code for Promisemed VeriEcto Automatic Biopsy Needles is KNW.

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 Promisemed Hangzhou Meditech Co., Ltd. como candidato(a)

K261719Promisemed X-Safety Pen Needle K261045Verifine Safety Lancets K254273Verisafe Safety Sterile Needles (SSN)K250192Verisafe Safety Retractable Insulin Syringes K250961Blood collection tube holders K251138Promisemed Safety Huber Needles

Ver todos os 36 dispositivos →

Dispositivos Relacionados (Código: KNW)

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, Inc.

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.