FDA 510(k)

2-Way 100% Silicone ClearTract Catheter

K 號：K221625 · 2022-07-01

決定日期2022-07-01

產品代碼EZL

諮詢委員會GU

決定相當於

器材摘要

2-Way 100% Silicone ClearTract Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Silq Technologies Corporation. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K221625. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 2-Way 100% Silicone ClearTract Catheter?

2-Way 100% Silicone ClearTract Catheter is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Silq Technologies Corporation. The 510(k) number is K221625.

When did 2-Way 100% Silicone ClearTract Catheter receive FDA 510(k) clearance?

2-Way 100% Silicone ClearTract Catheter received FDA 510(k) clearance on 2022-07-01, under 510(k) number K221625.

Who is the listed applicant for 2-Way 100% Silicone ClearTract Catheter?

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

What is the FDA product code for 2-Way 100% Silicone ClearTract Catheter?

The FDA product code for 2-Way 100% Silicone ClearTract Catheter is EZL.

其他以 Silq Technologies 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。

K2330132-Way 100% Silicone Cleartract Catheter

相關器械（代碼：EZL）

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

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