FDA 510(k)

OptaBlate 電波發生器，OptaBlate 探針，OptaBlate 微針注射器注射設備

K 號：K221074 · 2022-09-16

決定日期2022-09-16

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

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K221074. 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 OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Stryker Corporation. The 510(k) number is K221074.

When did OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device receive FDA 510(k) clearance?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221074.

Who is the listed applicant for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

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

What is the FDA product code for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

The FDA product code for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is GEI.

其他以 Stryker 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。

K232157連接設備與語音控制的OR Hub，配備設備與語音控制的SDC4K資訊管理系統 K223770Sonopet 1Q 3 7cm 1Q 大尺寸 K212194Stryker Q導航系統搭配頭顱導航軟體、CranialMask Tracker和顯微鏡Tracker、被動光學導航儀器、Mayfield基座搭配可屈節臂，以及導航針吸針，電磁導航儀器、精準定位系統 K221728Aviator® 頸椎前方板 (ACP) 系統，LITe® 板系統，DynaTran™ 頸椎前方板 (ACP) 系統，Reflex™ 混合 ACP 系統，UniVise™ 棘突固定板 K221098Scopis 耳鼻喉軟體，Scopis 耳鼻喉軟體搭配 TGS，Scopis 計劃軟體，電磁導航單元 K213824Sonopet iQ 超聲吸引器系統

查看所有 42 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。