Hem-o-lok™ 紫色加™ 大型聚合物結合夾
K 號：K251054 · 2025-07-03
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器材摘要
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K251054. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips?
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Teleflex Medical. The 510(k) number is K251054.
When did Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips receive FDA 510(k) clearance?
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips received FDA 510(k) clearance on 2025-07-03, under 510(k) number K251054.
Who is the listed applicant for Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips?
FDA 510(k) 記錄將Teleflex Medical列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips?
The FDA product code for Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips is FZP.
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。
其他以 Teleflex Medical 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。
相關器械（代碼：FZP）
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。
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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。
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