Apis (R), Veris (TM)

FDA 510(k) K222143 · Sweetbio, Inc.

Substantially Equivalent

510(k) numberK222143

Submission

Device name
Apis (R), Veris (TM)
Applicant
Sweetbio, Inc.
Memphis, TN, US
Received
July 20, 2022
Decision date
October 13, 2023
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 Apis (R), Veris (TM) cleared by the FDA?

Apis (R), Veris (TM) (K222143) received a 510(k) decision of Substantially Equivalent on October 13, 2023, 450 days after the submission was received.

What is the product code of K222143?

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