Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Surgical Direct Hand-held Laparoscopic Instruments

N.º K: K193018 · 2019-12-20

SolicitanteSurgical Direct, Inc.
Fecha de decisión2019-12-20
Código de productoGEI
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgical Direct Hand-held Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Direct, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193018. 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 Surgical Direct Hand-held Laparoscopic Instruments?

Surgical Direct Hand-held Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Surgical Direct, Inc.. The 510(k) number is K193018.

When did Surgical Direct Hand-held Laparoscopic Instruments receive FDA 510(k) clearance?

Surgical Direct Hand-held Laparoscopic Instruments received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193018.

Who is the listed applicant for Surgical Direct Hand-held Laparoscopic Instruments?

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

What is the FDA product code for Surgical Direct Hand-held Laparoscopic Instruments?

The FDA product code for Surgical Direct Hand-held Laparoscopic Instruments 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

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.

↑