FDA 510(k)

Isolator®Synergy®EnCompass夹具和引导系统（OLH，OSH，GPM100）

K号: K252056 · 2025-07-24

决定日期2025-07-24

产品代码OCL

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决定实质等同

器械摘要

Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2025-07-24 under 510(k) number K252056. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)?

Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is AtriCure, Inc.. The 510(k) number is K252056.

When did Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) receive FDA 510(k) clearance?

Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) received FDA 510(k) clearance on 2025-07-24, under 510(k) number K252056.

Who is the listed applicant for Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)?

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

What is the FDA product code for Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)?

The FDA product code for Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) is OCL.

列明AtriCure, 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。

K250371cryoICE cryoXT 冷冻消融探头（cryoXT）K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)K234151Isolator Synergy EnCapture消融系统（EMH）K234125AtriClip FLEX-Mini LAA 排除系统 (ACHM)K233959EPi-Ease epicardial access device (EAS)

查看所有 32 个设备 →

相关器械（代码：OCL）

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。

K234151Isolator Synergy EnCapture消融系统（EMH）AtriCure, Inc.K221358Isolator®线性笔（MLP1）；Isolator®Transpolar®笔（MAX1，MAX5），Coolrail®线性笔（MCR1）；Isolator®Synergy手术消融系统（EMR2，EML2）；Isolator®Synergy®EnCompass夹具（OLH，OSH）和引导系统；Isolator®Synergy Access夹具（EMT1）AtriCure, Inc.K223508Cardioblate Gemini-s 49260 外科消融设备；Cardioblate Gemini-s 49351 外科消融设备Medtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.K200514Cardioblate Gemini-s 外科消融设备Medtronic

官方来源

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