FDA 510(k)

ENDOCOLLECT 標本回收袋

K 號：K232519 · 2024-01-05

決定日期2024-01-05

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

ENDOCOLLECT Specimen Retrieval Bag is the device name listed in this FDA 510(k) record. The listed applicant is Ximedica. It received FDA 510(k) clearance on 2024-01-05 under 510(k) number K232519. 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 ENDOCOLLECT Specimen Retrieval Bag?

ENDOCOLLECT Specimen Retrieval Bag is a medical device that received FDA 510(k) clearance on 2024-01-05. The listed applicant is Ximedica. The 510(k) number is K232519.

When did ENDOCOLLECT Specimen Retrieval Bag receive FDA 510(k) clearance?

ENDOCOLLECT Specimen Retrieval Bag received FDA 510(k) clearance on 2024-01-05, under 510(k) number K232519.

Who is the listed applicant for ENDOCOLLECT Specimen Retrieval Bag?

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

What is the FDA product code for ENDOCOLLECT Specimen Retrieval Bag?

The FDA product code for ENDOCOLLECT Specimen Retrieval Bag is GCJ.

其他以 Ximedica 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。

K240635ENDOCOLLECT 標本回收袋，8mm，ENDOCOLLECT 標本回收袋，12mm，ENDOCOLLECT 標本回收袋，15mm

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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