FDA 510(k)

ENSEAL X1 絲組密封器，直型咬合，25 公分桿長，ENSEAL X1 絲組密封器，直型咬合，37 公分桿長

K 號：K201696 · 2021-01-22

決定日期2021-01-22

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K201696. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length?

ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K201696.

When did ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length receive FDA 510(k) clearance?

ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length received FDA 510(k) clearance on 2021-01-22, under 510(k) number K201696.

Who is the listed applicant for ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length?

FDA 510(k) 記錄中將 Ethicon Endo-Surgery, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length?

The FDA product code for ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length is GEI.

其他以 Ethicon Endo-Surgery, LLC 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：GEI）

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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