FDA 510(k)

i-Cut

K 號：K243821 · 2025-04-25

申請人A.M.I. Agency For Medical Innovations GmbH

決定日期2025-04-25

產品代碼HET

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

i-Cut is the device name listed in this FDA 510(k) record. The listed applicant is A.M.I. Agency For Medical Innovations GmbH. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243821. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the i-Cut?

i-Cut is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is A.M.I. Agency For Medical Innovations GmbH. The 510(k) number is K243821.

When did i-Cut receive FDA 510(k) clearance?

i-Cut received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243821.

Who is the listed applicant for i-Cut?

The FDA 510(k) record lists A.M.I. Agency For Medical Innovations GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-Cut?

The FDA product code for i-Cut is HET.

相關器械（代碼：HET）

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。

K250939SIRIUS內視鏡系統（PR-SI-1230）Precision Robotics (Hong Kong) Limited K221642SIRIUS內視鏡系統Precision Robotics (Hong Kong) Limited K210116視頻內視鏡系統，3D視頻內視鏡系統Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex 可變向視鏡與利康 LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope 系統270surgical , Ltd.K201617TipVision視覺內視鏡系統（TipVision VideoScope 0°/30°；EleVision HD 2 開關控制單元（CCU））Schoelly Fiberoptic GmbH

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。