FDA 510(k)

一次性組織切片針

K 號：K212819 · 2022-07-06

申請人Suzhou Leapmed Healthcare Corporation

決定日期2022-07-06

產品代碼FCG

諮詢委員會GU

決定相當於

器材摘要

Disposable Biopsy Refill Needle is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K212819. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Biopsy Refill Needle?

Disposable Biopsy Refill Needle is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212819.

When did Disposable Biopsy Refill Needle receive FDA 510(k) clearance?

Disposable Biopsy Refill Needle received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212819.

Who is the listed applicant for Disposable Biopsy Refill Needle?

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

What is the FDA product code for Disposable Biopsy Refill Needle?

The FDA product code for Disposable Biopsy Refill Needle is FCG.

其他以 Suzhou Leapmed Healthcare Corporation 為申請人之記錄

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相關器械（代碼：FCG）

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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