Class Class II
EndoFix™Tissue Fixation System (K251229)
Description
EndoFix™Tissue Fixation System by Softac Medical Technologies, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251229
Clearance Date2025-08-20
Clearance TypeTraditional
Product CodeFGE
Regulation Number876.5010
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251229
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. EndoFix™Tissue Fixation System (K251229) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201808 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2020 |
| K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Se... | Cook Incorporated | 2015 |
Trace the full predicate network for K251229
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.