FDA 510(k)

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch

N.º K: K193145 · 2020-03-24

SolicitanteMegadyne Medical Products, Inc.

Fecha de decisión2020-03-24

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 2020-03-24 under 510(k) number K193145. 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 Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is a medical device that received FDA 510(k) clearance on 2020-03-24. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K193145.

When did Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch receive FDA 510(k) clearance?

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch received FDA 510(k) clearance on 2020-03-24, under 510(k) number K193145.

Who is the listed applicant for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

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

What is the FDA product code for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

The FDA product code for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch 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 Megadyne Medical Products, Inc. como solicitante

K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)K213696ETHICON Megadyne Electrosurgical Generator K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor K191328Megadyne Foot Switch

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.