FDA 510(k)

Aqueduct 100 Plus 頸管擴張氣球導管

K 號：K202427 · 2020-11-06

決定日期2020-11-06

產品代碼PON

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

Aqueduct 100 Plus Cervical Dilation Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Gtimd, LLC. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K202427. The device is classified under product code PON. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

Aqueduct 100 Plus Cervical Dilation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Gtimd, LLC. The 510(k) number is K202427.

When did Aqueduct 100 Plus Cervical Dilation Balloon Catheter receive FDA 510(k) clearance?

Aqueduct 100 Plus Cervical Dilation Balloon Catheter received FDA 510(k) clearance on 2020-11-06, under 510(k) number K202427.

Who is the listed applicant for Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

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

What is the FDA product code for Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

The FDA product code for Aqueduct 100 Plus Cervical Dilation Balloon Catheter is PON.

其他以 Gtimd, 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。

K202433Aqueduct 200 頸管擴張氣球針筒 K160664Aqueduct 100 頸管擴張器

相關器械（代碼：PON）

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。

K202433Aqueduct 200 頸管擴張氣球針筒Gtimd, LLC K190813CrossBay 子宮頸擴張導尿管系統Crossbay Medical K160664Aqueduct 100 頸管擴張器Gtimd, LLC

官方來源

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