FDA 510(k)

Endoform 重構模板 - PLGA

K 號：K250598 · 2025-06-03

決定日期2025-06-03

產品代碼FTM

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

Endoform Reconstructive Template - PLGA is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K250598. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoform Reconstructive Template - PLGA?

Endoform Reconstructive Template - PLGA is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K250598.

When did Endoform Reconstructive Template - PLGA receive FDA 510(k) clearance?

Endoform Reconstructive Template - PLGA received FDA 510(k) clearance on 2025-06-03, under 510(k) number K250598.

Who is the listed applicant for Endoform Reconstructive Template - PLGA?

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

What is the FDA product code for Endoform Reconstructive Template - PLGA?

The FDA product code for Endoform Reconstructive Template - PLGA is FTM.

其他以 Aroa Biosurgery , Ltd. 為申請人之記錄

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相關器械（代碼：FTM）

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