FDA 510(k)

DemeDIOX 鋸針可吸收外科縫線

K 號：K191361 · 2019-11-07

決定日期2019-11-07

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

DemeDIOX Barbed Absorbable Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Demetech Corporation. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K191361. 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 DemeDIOX Barbed Absorbable Surgical Suture?

DemeDIOX Barbed Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Demetech Corporation. The 510(k) number is K191361.

When did DemeDIOX Barbed Absorbable Surgical Suture receive FDA 510(k) clearance?

DemeDIOX Barbed Absorbable Surgical Suture received FDA 510(k) clearance on 2019-11-07, under 510(k) number K191361.

Who is the listed applicant for DemeDIOX Barbed Absorbable Surgical Suture?

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

What is the FDA product code for DemeDIOX Barbed Absorbable Surgical Suture?

The FDA product code for DemeDIOX Barbed Absorbable Surgical Suture is NEW.

其他以 Demetech Corporation 為申請人之記錄

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。

K201479Deme口罩 K190777DemeTECH DemeFORCE 不吸收性外科縫線 K181578DemeTECH PTFE 不吸收性外科縫線 K181582DemeTECH DemeDIOX 可吸收外科縫線

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 Corporation K253879單點固定 PDOSamyang Holdings Corporation K261988Monodek™（多迪氧烷）染綠紫色單絲合成可吸收外科縫線Teleflex Medical, LLC K252171針刺型PDO縫線Sutura Medical Technology, Inc.K252047STRATAFIX™ 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.

官方來源

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