FDA 510(k)

耳鼻喉USB內視鏡系統

K 號：K254133 · 2026-05-14

決定日期2026-05-14

產品代碼EOB

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

ENTity USB Videoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Optim, LLC. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K254133. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ENTity USB Videoscope System?

ENTity USB Videoscope System is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Optim, LLC. The 510(k) number is K254133.

When did ENTity USB Videoscope System receive FDA 510(k) clearance?

ENTity USB Videoscope System received FDA 510(k) clearance on 2026-05-14, under 510(k) number K254133.

Who is the listed applicant for ENTity USB Videoscope System?

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

What is the FDA product code for ENTity USB Videoscope System?

The FDA product code for ENTity USB Videoscope System is EOB.

其他以 Optim, LLC 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。

K200609耳鼻喉科WiFi視頻鼻咽鏡系統

相關器械（代碼：EOB）

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。

K254299CLEARVISION 灌洗鞘 0° (7241AS)；CLEARVISION 灌洗鞘 30° (7241BS)；CLEARVISION 灌洗鞘 45° (7241FS)Karl Storz SE & CO. KG K261544水灌系統Stryker Instruments K253184視頻鼻咽喉鏡系統（一次性視頻鼻咽喉鏡 SP11A 結構光學處理器 M110B）Zhuhai Wesee Meditech Co., Ltd.K252050一次性活體切片镊子 FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation K241731Outlook外科Versa One系統（8900139）Resnent, LLC K243639Portare系統（FA-001）Grumpy Innovation, Inc.

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。