FDA 510(k)

DuoprossTM Smart Cap (Type I)

Número K: K252518 · 2025-12-17

Data da decisão2025-12-17

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

DuoprossTM Smart Cap (Type I) is the device name listed in this FDA 510(k) record. The listed applicant is Duopross Meditech Corporate. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K252518. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DuoprossTM Smart Cap (Type I)?

DuoprossTM Smart Cap (Type I) is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is Duopross Meditech Corporate. The 510(k) number is K252518.

When did DuoprossTM Smart Cap (Type I) receive FDA 510(k) clearance?

DuoprossTM Smart Cap (Type I) received FDA 510(k) clearance on 2025-12-17, under 510(k) number K252518.

Who is the listed applicant for DuoprossTM Smart Cap (Type I)?

The FDA 510(k) record lists Duopross Meditech Corporate as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuoprossTM Smart Cap (Type I)?

The FDA product code for DuoprossTM Smart Cap (Type I) is FMF.

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

Dispositivos Relacionados (Código: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., 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.