FDA 510(k)

SERFAS 90-S 電外科探針

K 號：K160050 · 2016-05-03

決定日期2016-05-03

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

SERFAS 90-S Electrosurgical Probe is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2016-05-03 under 510(k) number K160050. 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 SERFAS 90-S Electrosurgical Probe?

SERFAS 90-S Electrosurgical Probe is a medical device that received FDA 510(k) clearance on 2016-05-03. The listed applicant is Stryker Corporation. The 510(k) number is K160050.

When did SERFAS 90-S Electrosurgical Probe receive FDA 510(k) clearance?

SERFAS 90-S Electrosurgical Probe received FDA 510(k) clearance on 2016-05-03, under 510(k) number K160050.

Who is the listed applicant for SERFAS 90-S Electrosurgical Probe?

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 SERFAS 90-S Electrosurgical Probe?

The FDA product code for SERFAS 90-S Electrosurgical Probe 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。

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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.

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