FDA 510(k)

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device

N.º K: K221074 · 2022-09-16

Fecha de decisión2022-09-16

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K221074. 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 OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Stryker Corporation. The 510(k) number is K221074.

When did OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device receive FDA 510(k) clearance?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221074.

Who is the listed applicant for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

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

What is the FDA product code for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

The FDA product code for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion 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 Stryker Corporation como solicitante

K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control K223770Sonopet 1Q 3 7cm 1Q Large K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit K213824Sonopet iQ Ultrasonic Aspirator System

Ver todos los 42 dispositivos →

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.