FDA 510(k)

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil

N.º K: K200372 · 2020-11-30

SolicitanteModern Medical Equipment Manufacturing, Ltd.

Fecha de decisión2020-11-30

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. It received FDA 510(k) clearance on 2020-11-30 under 510(k) number K200372. 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 Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is a medical device that received FDA 510(k) clearance on 2020-11-30. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. The 510(k) number is K200372.

When did Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil receive FDA 510(k) clearance?

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil received FDA 510(k) clearance on 2020-11-30, under 510(k) number K200372.

Who is the listed applicant for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

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

What is the FDA product code for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

The FDA product code for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is GEI.

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Otros registros que enlistan a Modern Medical Equipment Manufacturing, Ltd. como solicitante

K210315Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps K211170Single Use Irrigation bipolar cable K192542Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

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

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