FDA 510(k)

多波段縫合器

K 號：K213223 · 2022-06-06

決定日期2022-06-06

產品代碼FHN

諮詢委員會GU

決定相當於

器材摘要

Multi-Band Ligator is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K213223. The device is classified under product code FHN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Multi-Band Ligator?

Multi-Band Ligator is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Beijing Zksk Technology Co., Ltd.. The 510(k) number is K213223.

When did Multi-Band Ligator receive FDA 510(k) clearance?

Multi-Band Ligator received FDA 510(k) clearance on 2022-06-06, under 510(k) number K213223.

Who is the listed applicant for Multi-Band Ligator?

The FDA 510(k) record lists Beijing Zksk Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Band Ligator?

The FDA product code for Multi-Band Ligator is FHN.

其他以 Beijing Zksk Technology Co., Ltd. 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。

K242192一次性括約肌斷刀 K231721一次性熱式組織切除镊 K213217一次性血夾 K213222一次性切除圈 K213239內視鏡注射針

相關器械（代碼：FHN）

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。

K172985結縫設備Leo Medical Co., Ltd.

官方來源

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