FDA 510(k)

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

Номер K: K161318 · 2017-03-20

ЗаявительTedan Surgical Innovations, LLC

Дата решения2017-03-20

Код продуктаGZT

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is the device name listed in this FDA 510(k) record. The listed applicant is Tedan Surgical Innovations, LLC. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K161318. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Tedan Surgical Innovations, LLC. The 510(k) number is K161318.

When did Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems receive FDA 510(k) clearance?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems received FDA 510(k) clearance on 2017-03-20, under 510(k) number K161318.

Who is the listed applicant for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

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

What is the FDA product code for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

The FDA product code for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is GZT.

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: GZT)

K252995Durashield Device KitSurGenTec, LLC K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH K172433NICO BrainPathNico Corporation

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.