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FDA 510(k)

DANNIK 標本回収系統配備機構，DANNIK 標本回収系統（僅含袋裝）

K 號：K200053 · 2020-04-21

申請人Dannik
決定日期2020-04-21
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) is the device name listed in this FDA 510(k) record. The listed applicant is Dannik. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K200053. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Dannik. The 510(k) number is K200053.

When did DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) receive FDA 510(k) clearance?

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) received FDA 510(k) clearance on 2020-04-21, under 510(k) number K200053.

Who is the listed applicant for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

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

What is the FDA product code for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

The FDA product code for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) is GCJ.

相關臨床試驗

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其他以 Dannik 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：GCJ）

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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