Rondek PGA 缝線（米色或紫羅蘭色）
K 號：K180625 · 2018-05-10
廣告
器材摘要
Rondek PGA Suture (Beige or Violet) is the device name listed in this FDA 510(k) record. The listed applicant is Rk Manufacturing Corporation. It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K180625. 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 Rondek PGA Suture (Beige or Violet)?
Rondek PGA Suture (Beige or Violet) is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Rk Manufacturing Corporation. The 510(k) number is K180625.
When did Rondek PGA Suture (Beige or Violet) receive FDA 510(k) clearance?
Rondek PGA Suture (Beige or Violet) received FDA 510(k) clearance on 2018-05-10, under 510(k) number K180625.
Who is the listed applicant for Rondek PGA Suture (Beige or Violet)?
The FDA 510(k) record lists Rk Manufacturing Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rondek PGA Suture (Beige or Violet)?
The FDA product code for Rondek PGA Suture (Beige or Violet) is GAM.
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。
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.K253530Trexon™ 单絲合成可吸收縫線MedtronicK253852MONOCRYL™ 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
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。
廣告