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FDA 510(k)

針刺型PDO縫線

K 號：K252171 · 2026-06-12

申請人Sutura Medical Technology, Inc.
決定日期2026-06-12
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

Barbed PDO Suture is the device name listed in this FDA 510(k) record. The listed applicant is Sutura Medical Technology, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252171. 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 Barbed PDO Suture?

Barbed PDO Suture is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Sutura Medical Technology, Inc.. The 510(k) number is K252171.

When did Barbed PDO Suture receive FDA 510(k) clearance?

Barbed PDO Suture received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252171.

Who is the listed applicant for Barbed PDO Suture?

The FDA 510(k) record lists Sutura Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Barbed PDO Suture?

The FDA product code for Barbed PDO Suture is NEW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：NEW）

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。

K254238MINT MONO 緝合針Hans Biomed CorporationK253879單點固定 PDOSamyang Holdings CorporationK261988Monodek™（多迪氧烷）染綠紫色單絲合成可吸收外科縫線Teleflex Medical, LLCK252047STRATAFIX™ 對稱 PDS™ Plus 無節結構組織控制設備ETHICON, Inc.K243897PDS™ Plus 抗菌（多氧烷酮）无菌合成可吸收外科縫線ETHICON, Inc.K251414Miracu™ 多氧二环酮 (PDO) 緝線及針 (單線)Feeltech Co., Ltd.

官方來源

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