FDA 510(k)

史特劳斯外科切除儀器

K 號：K253020 · 2026-06-04

決定日期2026-06-04

產品代碼HIH

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

Strauss Surgical Resection Instruments is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Endoscopy, Inc.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253020. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Strauss Surgical Resection Instruments?

Strauss Surgical Resection Instruments is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is American Medical Endoscopy, Inc.. The 510(k) number is K253020.

When did Strauss Surgical Resection Instruments receive FDA 510(k) clearance?

Strauss Surgical Resection Instruments received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253020.

Who is the listed applicant for Strauss Surgical Resection Instruments?

The FDA 510(k) record lists American Medical Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Strauss Surgical Resection Instruments?

The FDA product code for Strauss Surgical Resection Instruments is HIH.

其他以 American Medical Endoscopy, Inc. 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。

相關器械（代碼：HIH）

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。

K254252UNIDRIVE SIII 系統；HOPKINS 望遠鏡 0º (26205AMA) 作業套管 (26205CD) 塞子 (26205OC) 修鬆刀片 (26205SA) 修鬆刀片 (26205SB) 修鬆刀片 (091133-01/-10) 修鬆刀片 (091134-01/-10)Karl Storz SE & CO. KG K261102UNIDRIVE選擇系統Karl Storz SE & CO. KG K254294單次使用數位宮頸鏡（GYUT-A 12.6- 0、GYUT-A12.6- 12、GYUT-A 12.6- 22、GYUT-A 12.6- 30、GYUT-A 14.4- 0、GYUT-A 14.4- 12、GYUT-A 14.4- 22、GYUT-A 14.4- 30、GYUT-B 15- 0、GYUT-B 15- 12、GYUT-B 15-22、GYUT-B 15- 30）Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5切除設備（5FR1PK）；HERizon RD5切除設備 - 5入包裝（5FR5PK）Axora Medical, Inc.K254050手動組織移除設備Suzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument 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。