FDA 510(k)

V-soft Line™ 鋸齒外科縫線（各種）

K 號：K250107 · 2025-10-15

決定日期2025-10-15

產品代碼NEW

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

V-soft Line™ Barbed Surgical Suture (Various) is the device name listed in this FDA 510(k) record. The listed applicant is Feeltech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-15 under 510(k) number K250107. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the V-soft Line™ Barbed Surgical Suture (Various)?

V-soft Line™ Barbed Surgical Suture (Various) is a medical device that received FDA 510(k) clearance on 2025-10-15. The listed applicant is Feeltech Co., Ltd.. The 510(k) number is K250107.

When did V-soft Line™ Barbed Surgical Suture (Various) receive FDA 510(k) clearance?

V-soft Line™ Barbed Surgical Suture (Various) received FDA 510(k) clearance on 2025-10-15, under 510(k) number K250107.

Who is the listed applicant for V-soft Line™ Barbed Surgical Suture (Various)?

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

What is the FDA product code for V-soft Line™ Barbed Surgical Suture (Various)?

The FDA product code for V-soft Line™ Barbed Surgical Suture (Various) is NEW.

其他以 Feeltech Co., Ltd. 為申請人之記錄

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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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