FDA 510(k)

PlasmaBlade TnA Tonsil and Adenoid Dissection Device

N.º K: K152703 · 2016-07-08

Fecha de decisión2016-07-08

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PlasmaBlade TnA Tonsil and Adenoid Dissection Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K152703. 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 PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

PlasmaBlade TnA Tonsil and Adenoid Dissection Device is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K152703.

When did PlasmaBlade TnA Tonsil and Adenoid Dissection Device receive FDA 510(k) clearance?

PlasmaBlade TnA Tonsil and Adenoid Dissection Device received FDA 510(k) clearance on 2016-07-08, under 510(k) number K152703.

Who is the listed applicant for PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

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

What is the FDA product code for PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

The FDA product code for PlasmaBlade TnA Tonsil and Adenoid Dissection Device 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 Medtronic Advanced Energy como solicitante

K183129Medtronic Total Hip Arthroplasty System K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0 K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini K170610PlasmaBlade T K170296CoreCath 2.7S

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.