Class Class II
CROMA Electrosurgical Generator (PRD-EMR-050) (K242983)
Description
CROMA Electrosurgical Generator (PRD-EMR-050) by Creo Medical, Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242983
Clearance Date2025-02-05
Clearance TypeSpecial
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242983
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. CROMA Electrosurgical Generator (PRD-EMR-050) (K242983) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | 2023 |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2023 |
Trace the full predicate network for K242983
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.