FDA 510(k)

推薦 PaSoft 絇組維持設備

K 號：K230671 · 2023-05-31

決定日期2023-05-31

產品代碼FTL

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

Pitch PaSoft Tissue Reinforcement Device is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K230671. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pitch PaSoft Tissue Reinforcement Device?

Pitch PaSoft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Xiros, Ltd.. The 510(k) number is K230671.

When did Pitch PaSoft Tissue Reinforcement Device receive FDA 510(k) clearance?

Pitch PaSoft Tissue Reinforcement Device received FDA 510(k) clearance on 2023-05-31, under 510(k) number K230671.

Who is the listed applicant for Pitch PaSoft Tissue Reinforcement Device?

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

What is the FDA product code for Pitch PaSoft Tissue Reinforcement Device?

The FDA product code for Pitch PaSoft Tissue Reinforcement Device is FTL.

其他以 Xiros, Ltd. 為申請人之記錄

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相關器械（代碼：FTL）

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。

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官方來源

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