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FDA 510(k)

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

K-Number: K252056 · 2025-07-24

ApplicantAtriCure, Inc.
Decision Date2025-07-24
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

When was Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) approved by the FDA?

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

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

Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) is manufactured by AtriCure, Inc..

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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Related Devices (Code: OCL)

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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.

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