K261638
- 510(k) number
- K261638
- Device name
- Bonvadis®
- Applicant
- Oneness Biotech Co., Ltd. TW
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2026-06-17
- Date received
- 2026-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261638.pdf
Official FDA record: K261638
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.