FDA 510(k)

Soniquence 可重用雙極電纜

K 號：K211946 · 2021-07-16

決定日期2021-07-16

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

Soniquence Reusable Bipolar Cable is the device name listed in this FDA 510(k) record. The listed applicant is Soniquence, LLC. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K211946. 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 Soniquence Reusable Bipolar Cable?

Soniquence Reusable Bipolar Cable is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Soniquence, LLC. The 510(k) number is K211946.

When did Soniquence Reusable Bipolar Cable receive FDA 510(k) clearance?

Soniquence Reusable Bipolar Cable received FDA 510(k) clearance on 2021-07-16, under 510(k) number K211946.

Who is the listed applicant for Soniquence Reusable Bipolar Cable?

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

What is the FDA product code for Soniquence Reusable Bipolar Cable?

The FDA product code for Soniquence Reusable Bipolar Cable is GEI.

其他以 Soniquence, LLC 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。

K254220可重用三按鈕手指開關棒 K212222Soniquence 可重用 3 鈕手指開關棒 K220071Soniquence 可重用中性板 K190336Soniquence雙極電極 K183611Soniquence 電波發生器及 Soniquence 電極

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。

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 K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC 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。