FDA 510(k)

INLIANT Surgical Navigation System

Номер K: K213392 · 2022-02-22

ЗаявительNavigate Surgical Technologies, Inc.

Дата решения2022-02-22

Код продуктаPLV

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

INLIANT Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Navigate Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K213392. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the INLIANT Surgical Navigation System?

INLIANT Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Navigate Surgical Technologies, Inc.. The 510(k) number is K213392.

When did INLIANT Surgical Navigation System receive FDA 510(k) clearance?

INLIANT Surgical Navigation System received FDA 510(k) clearance on 2022-02-22, under 510(k) number K213392.

Who is the listed applicant for INLIANT Surgical Navigation System?

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

What is the FDA product code for INLIANT Surgical Navigation System?

The FDA product code for INLIANT Surgical Navigation System is PLV.

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: PLV)

K252376Yomi S Robotic SystemNeocis, Inc.K251835Yomi Robotic SystemNeocis, Inc.K233563NavidentClaronav, Inc.K231018Yomi Robotic SystemNeocis, Inc.K210947NavidentClaronav, Inc.K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.

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.