Class Class II
gi2000 Electrosurgical Generator (K250657)
Description
gi2000 Electrosurgical Generator by Cintron Medical Corporation, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250657
Clearance Date2025-06-03
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250657
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. gi2000 Electrosurgical Generator (K250657) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K113265 | GENII GI 4000 ELECTROSUGICAL GENERATOR | Genii, Inc. | 2012 |
Trace the full predicate network for K250657
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.