Class Class II
NPseal (20 and 25) (K241522)
Description
NPseal (20 and 25) by Guard Medical, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241522
Clearance Date2024-08-15
Clearance TypeSpecial
Product CodeOKO
Regulation Number878.4683
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241522
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. NPseal (20 and 25) (K241522) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | 2024 |
| K212971 | NPseal | Guard Medical, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250708 | NPseal | Guard Medical, Inc. | 2025 |
Trace the full predicate network for K241522
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.