FDA 510(k)

PENTAX Medical Video Colonoscope (EC38-i20cWL)

Número K: K242110 · 2025-01-03

Data da decisão2025-01-03

Código do produtoFDF

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PENTAX Medical Video Colonoscope (EC38-i20cWL) is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K242110. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PENTAX Medical Video Colonoscope (EC38-i20cWL)?

PENTAX Medical Video Colonoscope (EC38-i20cWL) is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Pentax of America, Inc.. The 510(k) number is K242110.

When did PENTAX Medical Video Colonoscope (EC38-i20cWL) receive FDA 510(k) clearance?

PENTAX Medical Video Colonoscope (EC38-i20cWL) received FDA 510(k) clearance on 2025-01-03, under 510(k) number K242110.

Who is the listed applicant for PENTAX Medical Video Colonoscope (EC38-i20cWL)?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical Video Colonoscope (EC38-i20cWL)?

The FDA product code for PENTAX Medical Video Colonoscope (EC38-i20cWL) is FDF.

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 Pentax of America, Inc. como candidato(a)

Ver todos os 39 dispositivos →

Dispositivos Relacionados (Código: FDF)

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC K260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics 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.