Class Class U
GeniPhys Collymer Self-Assembling Scaffold (K250329)
Description
GeniPhys Collymer Self-Assembling Scaffold by Geniphys, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK250329
Clearance Date2025-06-25
Clearance TypeTraditional
Product CodeKGN
FDA Database
View on FDA DatabasePredicate lineage for K250329
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. GeniPhys Collymer Self-Assembling Scaffold (K250329) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222025 | G4Derm / G4Derm Plus Synthetic Wound Matrix | Gel4med, Inc. | 2023 |
| K182681 | AC5 Topical Gel | Arch Therapeutics, Inc. | 2018 |
| K160136 | Flowable Wound Matrix | Cook Biotech Incorporated | 2016 |
| K072113 | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 | Integra Lifesciences Corp. | 2007 |
| K030774 | STIMULEN COLLAGEN | Southwest Technologies, Inc. | 2004 |
Trace the full predicate network for K250329
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.