FDA 510(k)

Fibras e Probes Cirúrgicas a Laser A.R.C.

Número K: K161403 · 2016-08-16

Data da decisão2016-08-16

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

A.R.C. Laser Surgical Fibers and Probes is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C Laser GmbH. It received FDA 510(k) clearance on 2016-08-16 under 510(k) number K161403. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the A.R.C. Laser Surgical Fibers and Probes?

A.R.C. Laser Surgical Fibers and Probes is a medical device that received FDA 510(k) clearance on 2016-08-16. The listed applicant is A.R.C Laser GmbH. The 510(k) number is K161403.

When did A.R.C. Laser Surgical Fibers and Probes receive FDA 510(k) clearance?

A.R.C. Laser Surgical Fibers and Probes received FDA 510(k) clearance on 2016-08-16, under 510(k) number K161403.

Who is the listed applicant for A.R.C. Laser Surgical Fibers and Probes?

The FDA 510(k) record lists A.R.C Laser GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A.R.C. Laser Surgical Fibers and Probes?

The FDA product code for A.R.C. Laser Surgical Fibers and Probes is GEX. This falls under the Gastroenterology category.

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 A.R.C Laser GmbH como candidato(a)

K220531FOX 810, FOX 980 K192272Wolf445nm K170183Cetus system, Cetus probe

Dispositivos Relacionados (Código: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T 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.