Bonvadis®

FDA 510(k) K261638 · Oneness Biotech Co., Ltd.

Substantially Equivalent

510(k) numberK261638

Submission

Device name
Bonvadis®
Applicant
Oneness Biotech Co., Ltd.
Taipei, TW
Received
May 18, 2026
Decision date
June 17, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 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 Bonvadis® cleared by the FDA?

Bonvadis® (K261638) received a 510(k) decision of Substantially Equivalent on June 17, 2026, 30 days after the submission was received.

What is the product code of K261638?

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