FDA 510(k)

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

Номер K: K172214 · 2017-08-23

ЗаявительG-21 S.R.L.

Дата решения2017-08-23

Код продуктаNDN

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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

Связанные устройства (Код: 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

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.