FDA 510(k)

Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)

K-Number: K252056 · 2025-07-24

Decision Date2025-07-24

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Other records listing AtriCure, Inc. as applicant

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Related Devices (Code: OCL)

K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.