Class Class II
HybridAPC probe (K243120)
Description
HybridAPC probe by Erbe Elektromedizin GmbH, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243120
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243120
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. HybridAPC probe (K243120) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160360 | Barrx FLEX RFA Energy Generator | Covidien, LLC | 2016 |
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 |
| K060183 | ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILT... | Erbe USA, Inc. | 2006 |
Trace the full predicate network for K243120
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.