FDA 510(k)

droplet® personal lancets

Número K: K250016 · 2025-07-01

Data da decisão2025-07-01

Código do produtoQRK

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

droplet® personal lancets is the device name listed in this FDA 510(k) record. The listed applicant is Htl-Strefa S.A. It received FDA 510(k) clearance on 2025-07-01 under 510(k) number K250016. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the droplet® personal lancets?

droplet® personal lancets is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Htl-Strefa S.A. The 510(k) number is K250016.

When did droplet® personal lancets receive FDA 510(k) clearance?

droplet® personal lancets received FDA 510(k) clearance on 2025-07-01, under 510(k) number K250016.

Who is the listed applicant for droplet® personal lancets?

The FDA 510(k) record lists Htl-Strefa S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for droplet® personal lancets?

The FDA product code for droplet® personal lancets is QRK.

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 Htl-Strefa S.A como candidato(a)

K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets K202340Droplet Pen Needle 30G & 33G K192082Droplet Pen Needle 34G K171982DROPLET PEN NEEDLE K170988DropSafe Safety Pen Needle

Dispositivos Relacionados (Código: QRK)

K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc.K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)SteriLance Medical (Suzhou), Inc.K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.K232330Lancing SystemNingbo Medsun Medical 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.