FDA 510(k)

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

N.º K: K172214 · 2017-08-23

Fecha de decisión2017-08-23

Código de productoNDN

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is the device name listed in this FDA 510(k) record. The listed applicant is G-21 S.R.L.. It received FDA 510(k) clearance on 2017-08-23 under 510(k) number K172214. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters?

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-08-23. The listed applicant is G-21 S.R.L.. The 510(k) number is K172214.

When did Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters receive FDA 510(k) clearance?

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance on 2017-08-23, under 510(k) number K172214.

Who is the listed applicant for Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA 510(k) record lists G-21 S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA product code for Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is NDN.

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

Dispositivos relacionados (Código: NDN)

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber Implants K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

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.