單極一次性內視鏡手術器械
K 號：K171523 · 2017-08-22
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器材摘要
Monopolar Single Use Laparoscopic Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Getsch+Hiller Medizintechnik GmbH. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K171523. 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 Monopolar Single Use Laparoscopic Instrument?
Monopolar Single Use Laparoscopic Instrument is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Getsch+Hiller Medizintechnik GmbH. The 510(k) number is K171523.
When did Monopolar Single Use Laparoscopic Instrument receive FDA 510(k) clearance?
Monopolar Single Use Laparoscopic Instrument received FDA 510(k) clearance on 2017-08-22, under 510(k) number K171523.
Who is the listed applicant for Monopolar Single Use Laparoscopic Instrument?
The FDA 510(k) record lists Getsch+Hiller Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Monopolar Single Use Laparoscopic Instrument?
The FDA product code for Monopolar Single Use Laparoscopic Instrument is GEI.
相關臨床試驗
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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。
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官方來源
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