FDA 510(k)

DemeTECH PTFE 不吸收性外科縫線

K 號：K181578 · 2018-10-11

決定日期2018-10-11

產品代碼NBY

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

DemeTECH PTFE Nonabsorbable 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 2018-10-11 under 510(k) number K181578. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DemeTECH PTFE Nonabsorbable Surgical Suture?

DemeTECH PTFE Nonabsorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Demetech Corporation. The 510(k) number is K181578.

When did DemeTECH PTFE Nonabsorbable Surgical Suture receive FDA 510(k) clearance?

DemeTECH PTFE Nonabsorbable Surgical Suture received FDA 510(k) clearance on 2018-10-11, under 510(k) number K181578.

Who is the listed applicant for DemeTECH PTFE Nonabsorbable 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 DemeTECH PTFE Nonabsorbable Surgical Suture?

The FDA product code for DemeTECH PTFE Nonabsorbable Surgical Suture is NBY.

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 K191361DemeDIOX 鋸針可吸收外科縫線 K190777DemeTECH DemeFORCE 不吸收性外科縫線 K181582DemeTECH DemeDIOX 可吸收外科縫線

相關器械（代碼：NBY）

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。

K231277組織統計器Durastat, LLC K192088GOLNIT 非吸收性聚四氟乙烯外科縫線Antarma, LLC Dba Golnit Sutures K180992生物特克斯Purgo Biologics, Inc.K191317釘織套件Origami Surgical K180630聚四氟乙烯外科縫線Omnia Spa K173922C-PTFETM 外科縫線Cp Medical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。