Class Class II
gentleheel® Adult Incision Device (K242664)
Description
gentleheel® Adult Incision Device by Gri-Alleset, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242664
Clearance Date2024-11-05
Clearance TypeTraditional
Product CodeFMK
Regulation Number878.4850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242664
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. gentleheel® Adult Incision Device (K242664) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Ne... | Gri-Alleset, Inc. | 2022 |
| K172712 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Ne... | Gri Medical & Electronic Technology... | 2017 |
Trace the full predicate network for K242664
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.