燙灼保護啟動系統（CPAS）
K 號：K232407 · 2023-10-06
廣告
器材摘要
Cautery Protective Actuation System (CPAS) is the device name listed in this FDA 510(k) record. The listed applicant is Safer Surgeries Medical Devices, LLC. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232407. 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 Cautery Protective Actuation System (CPAS)?
Cautery Protective Actuation System (CPAS) is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Safer Surgeries Medical Devices, LLC. The 510(k) number is K232407.
When did Cautery Protective Actuation System (CPAS) receive FDA 510(k) clearance?
Cautery Protective Actuation System (CPAS) received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232407.
Who is the listed applicant for Cautery Protective Actuation System (CPAS)?
The FDA 510(k) record lists Safer Surgeries Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cautery Protective Actuation System (CPAS)?
The FDA product code for Cautery Protective Actuation System (CPAS) is GEI.
相關臨床試驗
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。
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 InstrumentsK254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS 馬里蘭 頰部 血管 黏合器/分離器，納米塗層Covidien, LLCK254185波坦茲·普瑞美Jeisys Medical IncorporatedK262364艾利安恩尼格瑪雷射設備Ellian CorpK253859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。
廣告