Class Class U
Microdacyn Wound Care Solution (K233399)
Description
Microdacyn Wound Care Solution by Sonoma Pharmaceuticals, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK233399
Clearance Date2024-09-13
Clearance TypeTraditional
Product CodeFRO
FDA Database
View on FDA DatabasePredicate lineage for K233399
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. Microdacyn Wound Care Solution (K233399) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | 2018 |
| K172622 | Microcyn Antimicrobial Skin and Wound Cleanser | Sonoma Pharmaceuticals | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025 |
Trace the full predicate network for K233399
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.