FDA 510(k)

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

Número K: K221613 · 2022-10-03

Data da decisão2022-10-03

Código do produtoQRL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K221613. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K221613.

When did Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets receive FDA 510(k) clearance?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets received FDA 510(k) clearance on 2022-10-03, under 510(k) number K221613.

Who is the listed applicant for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

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

What is the FDA product code for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

The FDA product code for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is QRL.

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 Owen Mumford, Ltd. como candidato(a)

K223854Unistik® ShieldLock, Unistik VacuFlip K231124Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)K222168Unistik TinyTouch Steril Single-Use Heel Incisão Segurança Lancetas - Prematuro e Pós-Termo, Unistik Heelstik Steril Single-Use Heel Incisão Segurança Lancetas - MicroPrematuro, Prematuro, Pós-Termo e Criança K222303Unistik® Pro K222111Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets

Ver todos os 10 dispositivos →

Dispositivos Relacionados (Código: QRL)

K262135Lancing deviceTianjin Huahong Technology Co., Ltd.K262211LancetTianjin Huahong Technology Co., Ltd.K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology 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.