FDA 510(k)

BeneHold™ Surgical Incise Drape with CHG antimicrobial II

N.º K: K230645 · 2023-10-25

SolicitanteAvery Dennison Medical , Ltd.

Fecha de decisión2023-10-25

Código de productoKKX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Medical , Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K230645. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Avery Dennison Medical , Ltd.. The 510(k) number is K230645.

When did BeneHold™ Surgical Incise Drape with CHG antimicrobial II receive FDA 510(k) clearance?

BeneHold™ Surgical Incise Drape with CHG antimicrobial II received FDA 510(k) clearance on 2023-10-25, under 510(k) number K230645.

Who is the listed applicant for BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

The FDA 510(k) record lists Avery Dennison Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

The FDA product code for BeneHold™ Surgical Incise Drape with CHG antimicrobial II is KKX.

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

Dispositivos relacionados (Código: KKX)

K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba K200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, 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.