FDA 510(k)

Hem-o-lok® 鎖定夾

K 號：K232970 · 2024-01-12

決定日期2024-01-12

產品代碼FZP

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

Hem-o-lok® 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 2024-01-12 under 510(k) number K232970. 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® Ligating Clips?

Hem-o-lok® Ligating Clips is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Teleflex Medical. The 510(k) number is K232970.

When did Hem-o-lok® Ligating Clips receive FDA 510(k) clearance?

Hem-o-lok® Ligating Clips received FDA 510(k) clearance on 2024-01-12, under 510(k) number K232970.

Who is the listed applicant for Hem-o-lok® 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® Ligating Clips?

The FDA product code for Hem-o-lok® Ligating Clips is FZP.

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。

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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。

K260677血管封閉設備（VCD177213P）Vcd Medical S.R.L.K254231Inno-Hook™ 一次性釘針應用器（結扎釘針）及 Inno-Hook™ 結扎釘針Taiwan Surgical Corporation K253781InnoClip 錄片應用器Taiwan Surgical Corporation K253903InnoClip 一次性夾子施用器Taiwan Surgical Corporation K250643一次性聚合物結合夾Hangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ 紫色加™ 大型聚合物結合夾Teleflex Medical

官方來源

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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。