FDA 510(k)

Prevena Restor Adapti-Form Dressing

N.º K: K220660 · 2022-07-01

Fecha de decisión2022-07-01

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Prevena Restor Adapti-Form Dressing is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare Business Group. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K220660. 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 Prevena Restor Adapti-Form Dressing?

Prevena Restor Adapti-Form Dressing is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is 3M Healthcare Business Group. The 510(k) number is K220660.

When did Prevena Restor Adapti-Form Dressing receive FDA 510(k) clearance?

Prevena Restor Adapti-Form Dressing received FDA 510(k) clearance on 2022-07-01, under 510(k) number K220660.

Who is the listed applicant for Prevena Restor Adapti-Form Dressing?

The FDA 510(k) record lists 3M Healthcare Business Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prevena Restor Adapti-Form Dressing?

The FDA product code for Prevena Restor Adapti-Form Dressing 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 3M Healthcare Business Group como solicitante

K2215853M V.A.C. Veraflo Elección de Limpieza Completa Kit, 3M Veraflo Elección de Limpieza Completa Kit Completo K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing K2115213M Veraflo Elección de Limpieza Completa Kit (Kit de Vestiario Mediano: VFCCC05MD, Kit de Vestiario Grande: VFCCC05LG)K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac

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.