FDA 510(k)

FemChec 控制鹽水-空氣設備 (FCD-250)

K 號：K241693 · 2024-09-06

決定日期2024-09-06

產品代碼LKF

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

FemChec Controlled Saline-Air Device (FCD-250) is the device name listed in this FDA 510(k) record. The listed applicant is Femasys, Inc.. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K241693. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FemChec Controlled Saline-Air Device (FCD-250)?

FemChec Controlled Saline-Air Device (FCD-250) is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Femasys, Inc.. The 510(k) number is K241693.

When did FemChec Controlled Saline-Air Device (FCD-250) receive FDA 510(k) clearance?

FemChec Controlled Saline-Air Device (FCD-250) received FDA 510(k) clearance on 2024-09-06, under 510(k) number K241693.

Who is the listed applicant for FemChec Controlled Saline-Air Device (FCD-250)?

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

What is the FDA product code for FemChec Controlled Saline-Air Device (FCD-250)?

The FDA product code for FemChec Controlled Saline-Air Device (FCD-250) is LKF.

其他以 Femasys, 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。

K253403FemVue® 控制鹽水-空氣設備 (FSA-300)K242002FemVue MINI鹽水-空氣設備 K231730FemaSeed 鼓室內射精器

相關器械（代碼：LKF）

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。

K253403FemVue® 控制鹽水-空氣設備 (FSA-300)Femasys, Inc.K252260RELIEEV HSG 腹腔鏡導管 (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI鹽水-空氣設備Femasys, Inc.K240364RELIEEV 子宮操作注射器（CUMI 5.0）Li Medical Corporation , Ltd.K222798Rejoni 子宮內腔導管Rejoni, Inc.K223064ALLY II 子宮定位系統™ (UPS)CooperSurgical, Inc.

官方來源

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