FDA 510(k)

Iovera System

Номер K: K211334 · 2021-09-10

Дата решения2021-09-10

Код продуктаGXH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Iovera System is the device name listed in this FDA 510(k) record. The listed applicant is Pacira Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K211334. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Iovera System?

Iovera System is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Pacira Pharmaceuticals, Inc.. The 510(k) number is K211334.

When did Iovera System receive FDA 510(k) clearance?

Iovera System received FDA 510(k) clearance on 2021-09-10, under 510(k) number K211334.

Who is the listed applicant for Iovera System?

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

What is the FDA product code for Iovera System?

The FDA product code for Iovera System is GXH.

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.

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Связанные устройства (Код: GXH)

K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.K243677iovera° SystemPacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)AtriCure, Inc.K220656iovera SystemPacira Biosciences, Inc.K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc.

Официальный источник

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