FDA 510(k)

Genadyne Hybrid Foam Dressings

N.º K: K221888 · 2023-06-12

SolicitanteGenadyne Biotechnologies, Inc.

Fecha de decisión2023-06-12

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Genadyne Hybrid Foam Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K221888. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Genadyne Hybrid Foam Dressings?

Genadyne Hybrid Foam Dressings is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K221888.

When did Genadyne Hybrid Foam Dressings receive FDA 510(k) clearance?

Genadyne Hybrid Foam Dressings received FDA 510(k) clearance on 2023-06-12, under 510(k) number K221888.

Who is the listed applicant for Genadyne Hybrid Foam Dressings?

The FDA 510(k) record lists Genadyne Biotechnologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genadyne Hybrid Foam Dressings?

The FDA product code for Genadyne Hybrid Foam Dressings is OMP.

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 Genadyne Biotechnologies, Inc. como solicitante

K253429Genadyne ASTRA NPWT K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)K233614Genadyne DUO NPWT K221891UNO Negative Pressure Wound Therapy System K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System K180840UNO Negative Pressure Wound Therapy System

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

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.