Bonvadis®— 510(k) K261638
Substantially EquivalentOneness Biotech Co., Ltd.
FDA 510(k) clearance K261638 for Bonvadis®, Substantially Equivalent on 2026-06-17. Applicant: Oneness Biotech Co., Ltd.. Device class: Unclassified.
Summary
Bonvadis from Oneness Biotech is filed under FRO, drug wound dressings. The record doesn't describe the product beyond its name and the code name.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The General and Plastic Surgery review panel handled it as a Special 510(k).
Oneness Biotech filed from Taipei, Taiwan. The decision came 30 calendar days after FDA received it (May 18 to June 17, 2026).
Clearance details
- Applicant
- Oneness Biotech Co., Ltd.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Taipei, TW
Recent devices under product code FRO
view allMore clearances from Oneness Biotech Co., Ltd.
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.