FDA 510(k)

Kitazato OPU Needles

Número K: K162881 · 2017-07-11

Data da decisão2017-07-11

Código do produtoMQE

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kitazato OPU Needles is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K162881. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kitazato OPU Needles?

Kitazato OPU Needles is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Kitazato Corporation. The 510(k) number is K162881.

When did Kitazato OPU Needles receive FDA 510(k) clearance?

Kitazato OPU Needles received FDA 510(k) clearance on 2017-07-11, under 510(k) number K162881.

Who is the listed applicant for Kitazato OPU Needles?

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

What is the FDA product code for Kitazato OPU Needles?

The FDA product code for Kitazato OPU Needles is MQE.

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 Kitazato Corporation como candidato(a)

K260248Ultra-Fast Warm K251305Ultra-Fast Vitri; Ultra-Fast Warm K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA K192845Sperm Freeze, Sperm Fridge K192540Kitazato ET Catheters

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: MQE)

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval NeedleGimbo Medical Technology Shenzhen Co., Ltd.K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)Shenzhen Vitavitro Biotech Co., Ltd.K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleZhejiang Horizon Medical Technology Co., Ltd.K190590Agulhas de Retirada de Ovário Allwin (Agulha de Retirada de Ovário de Único Lumeno ACE, Agulha de Retirada de Ovário de Duplo Lumeno OVUMPICK, Agulha de Retirada de Ovário de Único Lumeno com Linha de Limpeza ACE-FL, Agulha de Retirada de Ovário Manual de Único Lumeno ACE-M)Allwin Medical Devices, Inc.K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, 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.