FDA 510(k)

CleanSeal 高級雙極血管封閉器馬里蘭

K 號：K231732 · 2023-10-23

決定日期2023-10-23

產品代碼GEI

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

CleanSeal Advanced Bipolar Vessel Sealer Maryland is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K231732. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CleanSeal Advanced Bipolar Vessel Sealer Maryland?

CleanSeal Advanced Bipolar Vessel Sealer Maryland is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is Conmed Corporation. The 510(k) number is K231732.

When did CleanSeal Advanced Bipolar Vessel Sealer Maryland receive FDA 510(k) clearance?

CleanSeal Advanced Bipolar Vessel Sealer Maryland received FDA 510(k) clearance on 2023-10-23, under 510(k) number K231732.

Who is the listed applicant for CleanSeal Advanced Bipolar Vessel Sealer Maryland?

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

What is the FDA product code for CleanSeal Advanced Bipolar Vessel Sealer Maryland?

The FDA product code for CleanSeal Advanced Bipolar Vessel Sealer Maryland is GEI.

其他以 Conmed Corporation 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。

K261363Y-Knotless™ 非結節式靈活釘 K253763Y-Knotless™ 非結節式靈活釘 K252946BioBrace® 間節韌帶增強組合 K251530CONMED 阿爾戈 Knotless® 抓釘 K250395BioBrace® RC 交付系統 K244025Argo Knotless GENESYS Anchor

查看所有 47 項裝置 →

相關器械（代碼：GEI）

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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片，按鈕開關（0703-046-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，按鈕開關，大量非無菌（0703-046-102）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片， rocking 開關（0703-047-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，rocking 開關，大量非無菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 馬里蘭頰部血管黏合器/分離器，納米塗層Covidien, LLC K254185波坦茲·普瑞美Jeisys Medical Incorporated K262364艾利安恩尼格瑪雷射設備Ellian Corp K253859紅色專業版（Scarlet Pro）VIOL 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。