FDA 510(k)

iovera° 系統

K 號：K243677 · 2024-12-26

決定日期2024-12-26

產品代碼GXH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

iovera° System is the device name listed in this FDA 510(k) record. The listed applicant is Pacira Biosciences, Inc.. It received FDA 510(k) clearance on 2024-12-26 under 510(k) number K243677. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iovera° System?

iovera° System is a medical device that received FDA 510(k) clearance on 2024-12-26. The listed applicant is Pacira Biosciences, Inc.. The 510(k) number is K243677.

When did iovera° System receive FDA 510(k) clearance?

iovera° System received FDA 510(k) clearance on 2024-12-26, under 510(k) number K243677.

Who is the listed applicant for iovera° System?

The FDA 510(k) record lists Pacira Biosciences, 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.

其他以 Pacira Biosciences, Inc. 為申請人之記錄

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K220656iovera 系統

相關器械（代碼：GXH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250371cryoICE cryoXT 冷凍消融探針 (cryoXT)AtriCure, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ 冷凍消融探針 (CRYOSP)；cryoICE cryoSPHERE+ 冷凍消融探針 (CRYOSP-L)；cryoICE cryoSPHERE MAX 冷凍消融探針 (CRYOSMAX)；cryoICE cryoSPHERE MAX 冷凍消融探針 (CRYOSMAX-L)AtriCure, Inc.K220656iovera 系統Pacira Biosciences, Inc.K211334Iovera 系統Pacira Pharmaceuticals, Inc.K200697AtriCure cryoICE 冷凍消融探針 (Cryo2), AAtriCure cryoICE 冷凍SPHERE 冷凍消融探針 (CryoS, CryoS-L)AtriCure, Inc.

官方來源

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