Class Class II
Isolator Synergy EnCapture Ablation System (EMH) (K234151)
Description
Isolator Synergy EnCapture Ablation System (EMH) by AtriCure, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234151
Clearance Date2024-08-27
Clearance TypeTraditional
Product CodeOCL
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234151
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 EnCapture Ablation System (EMH) (K234151) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | AtriCure, Inc. | 2021 |
| K123077 | VASCULAR CLAMPS | Hebumedical GmbH | 2013 |
Trace the full predicate network for K234151
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.