Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

DuoprossTM Smart Cap (Type I)

N.º K: K252518 · 2025-12-17

SolicitanteDuopross Meditech Corporate
Fecha de decisión2025-12-17
Código de productoFMF
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: FMF)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-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, LLCK253110Sol-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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑