510(k) K261638
K261638 is an FDA 510(k) premarket notification submitted by Oneness Biotech Co., Ltd. for the device "Bonvadis®". The FDA issued a decision of Substantially Equivalent on June 17, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Oneness Biotech Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2026
- Date Received
- May 18, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type