FDA 510(k)

WEREWOLF COBLATION System, COBLATION HALO Wand

N.º K: K192027 · 2019-12-20

Fecha de decisión2019-12-20

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

WEREWOLF COBLATION System, COBLATION HALO Wand is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192027. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the WEREWOLF COBLATION System, COBLATION HALO Wand?

WEREWOLF COBLATION System, COBLATION HALO Wand is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is ArthroCare Corporation. The 510(k) number is K192027.

When did WEREWOLF COBLATION System, COBLATION HALO Wand receive FDA 510(k) clearance?

WEREWOLF COBLATION System, COBLATION HALO Wand received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192027.

Who is the listed applicant for WEREWOLF COBLATION System, COBLATION HALO Wand?

The FDA 510(k) record lists ArthroCare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WEREWOLF COBLATION System, COBLATION HALO Wand?

The FDA product code for WEREWOLF COBLATION System, COBLATION HALO Wand is GEI.

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 ArthroCare Corporation como solicitante

K254122FLOW FLEXTEND Wand (72290039)K253680LYNX COBLATION Laryngeal Wand (72290254)K240964FLOW 90? Wand K232290INTELLIO SHIFT System K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)K220563Ambient HipVac 50 Mango con Interruptor de Dedo Integrado, Sistema de COBLATION RF20000, Sistema de COBLATION WEREWOLF, Sistema de COBLATION WEREWOLF+

Ver todos los 17 dispositivos →

Dispositivos relacionados (Código: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., 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.