FDA 510(k)

TargetCool-e 注意：此翻譯僅根據規定進行，並未考慮具體的醫療設備規範細節。如需更詳細的翻譯，請提供完整的文本。

K 號：K253348 · 2025-10-15

決定日期2025-10-15

產品代碼GEH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

TargetCool-e is the device name listed in this FDA 510(k) record. The listed applicant is Recensmedical, Inc.. It received FDA 510(k) clearance on 2025-10-15 under 510(k) number K253348. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TargetCool-e?

TargetCool-e is a medical device that received FDA 510(k) clearance on 2025-10-15. The listed applicant is Recensmedical, Inc.. The 510(k) number is K253348.

When did TargetCool-e receive FDA 510(k) clearance?

TargetCool-e received FDA 510(k) clearance on 2025-10-15, under 510(k) number K253348.

Who is the listed applicant for TargetCool-e?

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

What is the FDA product code for TargetCool-e?

The FDA product code for TargetCool-e is GEH.

其他以 Recensmedical, Inc. 為申請人之記錄

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。

K253114TargetCool™ (RM-DT02W)K230599TargetCool™K221234目標冷 K220674目標冷 K203481冷凍維持

相關器械（代碼：GEH）

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。

K262420Maverix 冷凍切片儀 Pro (MCB Pro) (MCBP-1000)；Maverix 冷凍針筒 (CC-1000)Serpex Medical K261068Maverix冷凍切片探針（MCB1000）；Maverix冷凍針筒（CC1000）Serpex Medical K261806ERBECRYO 2 冷凍外科儀器及附件Erbe Elektromedizin GmbH K253230ERBECRYO 2 冷凍外科儀器及附件：ERBECRYO 2 冷凍外科儀器；Erbe 柔性冷凍針Erbe Elektromedizin GmbH K252198Advanced 冷冻皮肤疣去除器（Advanced 皮肤疣去除器）Medical Brands Laboratories B.V.K260377XSense冷凍消融系統搭配冷凍探針IceCure Medical , Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。