Class Class II
T-Line Hernia Mesh (K230227)
Description
T-Line Hernia Mesh by Deep Blue Medical Advances, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230227
Clearance Date2023-02-23
Clearance TypeSpecial
Product CodeFTL
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230227
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. T-Line Hernia Mesh (K230227) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2022 |
| K193144 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2020 |
| K172636 | VitaMESH Macroporous PP Surgical Mesh | Proxy Biomedical , Ltd. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023 |
Trace the full predicate network for K230227
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.