FDA 510(k)

Pollogen Legend System

Número K: K173503 · 2018-06-11

Data da decisão2018-06-11

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pollogen Legend System is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2018-06-11 under 510(k) number K173503. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pollogen Legend System?

Pollogen Legend System is a medical device that received FDA 510(k) clearance on 2018-06-11. The listed applicant is Pollogen, Ltd.. The 510(k) number is K173503.

When did Pollogen Legend System receive FDA 510(k) clearance?

Pollogen Legend System received FDA 510(k) clearance on 2018-06-11, under 510(k) number K173503.

Who is the listed applicant for Pollogen Legend System?

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

What is the FDA product code for Pollogen Legend System?

The FDA product code for Pollogen Legend System is GEI.

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 Pollogen, Ltd. como candidato(a)

K242227GENEO X ELITE K252576Plataforma Legend X K250734OptiLUV Device K243217Legend X Desktop System K240999Legend X Applicator VO K233766Geneo X Elite

Ver todos os 14 dispositivos →

Dispositivos Relacionados (Código: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL 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.