FDA 510(k)

FITme 適用式矽膠植入體

K 號：K232593 · 2023-11-22

決定日期2023-11-22

產品代碼FWP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

FITme Customized Silicone Implant is the device name listed in this FDA 510(k) record. The listed applicant is Keosan Trading Co.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K232593. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FITme Customized Silicone Implant?

FITme Customized Silicone Implant is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Keosan Trading Co.. The 510(k) number is K232593.

When did FITme Customized Silicone Implant receive FDA 510(k) clearance?

FITme Customized Silicone Implant received FDA 510(k) clearance on 2023-11-22, under 510(k) number K232593.

Who is the listed applicant for FITme Customized Silicone Implant?

The FDA 510(k) record lists Keosan Trading Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FITme Customized Silicone Implant?

The FDA product code for FITme Customized Silicone Implant is FWP.

其他以 Keosan Trading Co. 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。

K241150MISTI矽膠植入物

相關器械（代碼：FWP）

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。

K254233醫用設備規範文本翻譯： MEDPOR客製化植入套件Stryker Leibinger GmbH & Co KG K200610客製化外型植入體Implantech Associates, Inc.K191130客製化外型植入體Implantech Associates, Inc.K191916Stryker CMF MEDPOR 優先級客製化植入器材套件Stryker Leibinger GmbH & Co KG K153508Stryker CMF 医用設備規範文本 Stryker CMF 匯編式植體Stryker K152463SU-POR 頭部專屬植入物，SU-POR 面部專屬植入物Poriferous, LLC

官方來源

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