Class Class II
AtriCure cryoICE BOX (ACM) (K243157)
Description
AtriCure cryoICE BOX (ACM) by AtriCure, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243157
Clearance Date2024-10-29
Clearance TypeSpecial
Product CodeGXH
Regulation Number882.4250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243157
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. AtriCure cryoICE BOX (ACM) (K243157) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 |
Trace the full predicate network for K243157
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.