Class Class U
Microlyte Ag/Lidocaine (K211943)
Description
Microlyte Ag/Lidocaine by Imbed Biosciences, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK211943
Clearance Date2024-10-17
Clearance TypeTraditional
Product CodeFRO
FDA Database
View on FDA DatabasePredicate lineage for K211943
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. Microlyte Ag/Lidocaine (K211943) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153756 | Microlyte Ag | Imbed Biosciences, Inc. | 2016 |
| K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A202... | Amerx Health Care Corp. | 2009 |
| K053476 | ALLWOUND | At Squared, LLC | 2006 |
Trace the full predicate network for K211943
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.