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FDA 510(k)

Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil

N.º K: K170721 · 2017-04-21

SolicitantePrecision Surgical, LLC
Fecha de decisión2017-04-21
Código de productoGEI
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil is the device name listed in this FDA 510(k) record. The listed applicant is Precision Surgical, LLC. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K170721. 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 Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil?

Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Precision Surgical, LLC. The 510(k) number is K170721.

When did Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil receive FDA 510(k) clearance?

Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil received FDA 510(k) clearance on 2017-04-21, under 510(k) number K170721.

Who is the listed applicant for Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil?

The FDA 510(k) record lists Precision Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil?

The FDA product code for Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil is GEI.

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Dispositivos relacionados (Código: GEI)

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.

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261959Neptune® 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 InstrumentsK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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