Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056)
Description
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) by AtriCure, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
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Predicate lineage for K252056
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magn... | AtriCure, Inc. | 2021 |
Trace the full predicate network for K252056
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.