FDA 510(k)

POWERSEAL 開放式延長夾具封合機及分離器，雙動作（PS-0021EJDA）

K 號：K252487 · 2026-03-02

決定日期2026-03-02

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

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K252487. 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 POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)?

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K252487.

When did POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) receive FDA 510(k) clearance?

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) received FDA 510(k) clearance on 2026-03-02, under 510(k) number K252487.

Who is the listed applicant for POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)?

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

What is the FDA product code for POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)?

The FDA product code for POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is GEI.

其他以 Gyrus Acmi, Inc. 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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