FDA 510(k)

xPORT 304 (miCOR) System Lens Fragmentation System

Número K: K200584 · 2020-07-31

RequerenteCarl Zeiss Meditec Cataract Technology, Inc.

Data da decisão2020-07-31

Código do produtoHQC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

xPORT 304 (miCOR) System Lens Fragmentation System is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K200584. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the xPORT 304 (miCOR) System Lens Fragmentation System?

xPORT 304 (miCOR) System Lens Fragmentation System is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K200584.

When did xPORT 304 (miCOR) System Lens Fragmentation System receive FDA 510(k) clearance?

xPORT 304 (miCOR) System Lens Fragmentation System received FDA 510(k) clearance on 2020-07-31, under 510(k) number K200584.

Who is the listed applicant for xPORT 304 (miCOR) System Lens Fragmentation System?

The FDA 510(k) record lists Carl Zeiss Meditec Cataract Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for xPORT 304 (miCOR) System Lens Fragmentation System?

The FDA product code for xPORT 304 (miCOR) System Lens Fragmentation System is HQC.

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 Carl Zeiss Meditec Cataract Technology, Inc. como candidato(a)

K243395MICOR 700 with Auto I/A K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)K214028MICOR Lens Fragmentation System K222236miCOR System Lens Fragmentation System K200207xPORT S Lens Fragmentation System K191024xPORT Lens Fragmentation System

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: HQC)

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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.