FDA 510(k)

POWERSEAL 开放扩展嘴封口器和分隔器，双动作（PS-0021EJDA）

K号: K252487 · 2026-03-02

决定日期2026-03-02

产品代码GEI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Gyrus Acmi, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233275RenaFlex 单次使用柔性输尿管镜（SUURF-V 标准型）；RenaFlex 单次使用柔性输尿管镜（SUURF-VR 反向型）；单次使用内窥镜视频系统中心（CV-S1）K231327POWERSEAL 封口器和分隔器 K221306SOLTIVE Pro超脉冲激光，SOLTIVE Premium超脉冲激光，SOLTIVE超脉冲激光光纤和附件 K212650Celeris, 一次性窦道清创器 K213831Olympus PK 电外科器械，PK J钩，PK 刮刀，PK 针 K211401SOLTIVE激光系统（SOLTIVE Pro超脉冲激光，SOLTIVE Premium超脉冲激光，SOLTIVE激光光纤和附件）

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相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

官方来源

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