Class Class U
Granudacyn® Wound Irrigation Solution (K243415)
Description
Granudacyn® Wound Irrigation Solution by P.G.F. Industry Solutions GmbH, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK243415
Clearance Date2025-07-22
Clearance TypeTraditional
Product CodeFRO
FDA Database
View on FDA DatabasePredicate lineage for K243415
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. Granudacyn® Wound Irrigation Solution (K243415) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024 |
| K131848 | VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 |
Trace the full predicate network for K243415
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.