Microlyte Ag/Lidocaine

FDA 510(k) K211943 · Imbed Biosciences

Substantially Equivalent

510(k) numberK211943

Submission

Device name
Microlyte Ag/Lidocaine
Applicant
Imbed Biosciences
Fitchburg, WI, US
Received
June 23, 2021
Decision date
October 17, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRO – Dressing, Wound, Drug
Device class
Unclassified

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Questions and answers

When was Microlyte Ag/Lidocaine cleared by the FDA?

Microlyte Ag/Lidocaine (K211943) received a 510(k) decision of Substantially Equivalent on October 17, 2024, 1,212 days after the submission was received.

What is the product code of K211943?

The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.