FDA 510(k)

COOLIEF 冷卻式電波刀組高級版

K 號：K203066 · 2020-12-22

決定日期2020-12-22

產品代碼GXI

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

COOLIEF Cooled Radiofrequency Kit Advanced is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K203066. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the COOLIEF Cooled Radiofrequency Kit Advanced?

COOLIEF Cooled Radiofrequency Kit Advanced is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K203066.

When did COOLIEF Cooled Radiofrequency Kit Advanced receive FDA 510(k) clearance?

COOLIEF Cooled Radiofrequency Kit Advanced received FDA 510(k) clearance on 2020-12-22, under 510(k) number K203066.

Who is the listed applicant for COOLIEF Cooled Radiofrequency Kit Advanced?

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

What is the FDA product code for COOLIEF Cooled Radiofrequency Kit Advanced?

The FDA product code for COOLIEF Cooled Radiofrequency Kit Advanced is GXI.

其他以 Avanos Medical, 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。

K243572Game Ready系統（550500-04）；Game Ready控制單元（550550-04）；Game Ready全腿靴包-中號（590923-04）；Game Ready全腿靴包-大號（590922-04）；Game Ready C-T脊椎包（590502-04）；Game Ready半腿靴（590906-04）；Game Ready背部包（590500-04）；Game Ready手/手腕包（590811-04）；Game Ready彎曲肘包（590903-04）；Game Ready直肘包（590200-04）；Game Ready肩膀包，中號，右邊（590422-04）；Game Ready肩膀包，La K241185CORGRIP* SR NG/NI 管道固定系統 K242057COOLIEF* 電頻發生器 (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)K240965CORTRAK* 2 腹腔內進入系統 (20-0950)K220588Avanos* CORTRAK* 2 腸道進入系統 (EAS)K192491Coolief 開放式射頻產生器系統 (CRG)

查看所有 8 項裝置 →

相關器械（代碼：GXI）

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。

K253907一次性射頻針管ABBOTT MEDICAL K251802STAR 電波消融系統Merit Medical Systems, Inc.K251243OneRF 三叉神經開放式頻率探針Neuroone Medical Technologies Corp.K242841一次性RF電極（RFDE-5/RFDE-10/RFDE-15/RFDE-20）ABBOTT MEDICAL K250213OptaBlate BVN 骨內神經消融系統（10mm 探針單套組）；OptaBlate BVN 骨內神經消融系統（10mm 探針雙套組）Stryker Instruments K241367RF針管Shanghai Samedical & Plastic Instruments Co., 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。