FDA 510(k)

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

N.º K: K162442 · 2016-12-12

SolicitanteGri Medical & Electrical Technology Co., Ltd.

Fecha de decisión2016-12-12

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162442. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K162442.

When did ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 receive FDA 510(k) clearance?

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162442.

Who is the listed applicant for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

The FDA 510(k) record lists Gri Medical & Electrical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500?

The FDA product code for ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 is FYA.

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_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

Otros registros que enlistan a Gri Medical & Electrical Technology Co., Ltd. como solicitante

K172445RoyalGuard Surgical Gown, i600, Breathable K163191ComfortGuard Surgical Gown, i600, Film Reinforced

Dispositivos relacionados (Código: FYA)

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

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.