FDA 510(k)

Trexon™ 单絲合成可吸收縫線

K 號：K253530 · 2026-05-28

決定日期2026-05-28

產品代碼GAM

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

Trexon™ Monofilament Synthetic Absorbable Suture is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K253530. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Trexon™ Monofilament Synthetic Absorbable Suture?

Trexon™ Monofilament Synthetic Absorbable Suture is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Medtronic. The 510(k) number is K253530.

When did Trexon™ Monofilament Synthetic Absorbable Suture receive FDA 510(k) clearance?

Trexon™ Monofilament Synthetic Absorbable Suture received FDA 510(k) clearance on 2026-05-28, under 510(k) number K253530.

Who is the listed applicant for Trexon™ Monofilament Synthetic Absorbable Suture?

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

What is the FDA product code for Trexon™ Monofilament Synthetic Absorbable Suture?

The FDA product code for Trexon™ Monofilament Synthetic Absorbable Suture is GAM.

其他以 Medtronic 為申請人之記錄

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相關器械（代碼：GAM）

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。

K253394包覆維克萊™（多甘膠910）加抗菌縫線ETHICON, Inc.K253852MONOCRYL™ Plus 抗菌多甘露聚糖 - 25（單絲），无菌合成可吸收外科縫線ETHICON, Inc.K252743STRATAFIX™螺旋PDS™ Plus無結紮組織控制裝置；STRATAFIX™螺旋MONOCRYL™無結紮組織控制裝置ETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 聚(甘醇酸-共-L-乳酸)外科縫線（卡利普索）；PGLA90 聚(甘醇酸-共-L-乳酸)外科縫線（奧德賽斯）Internacional Farmacéutica S.A DE C.V K233265Monotime及Optime RPeters Surgical

官方來源

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