510(k) K261646
K261646 is an FDA 510(k) premarket notification submitted by Beijing Kreate Medical Co., Ltd. for the device "Redermax® Antibacterial Wound Matrix". The FDA issued a decision of Substantially Equivalent on Aug 14, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Beijing Kreate Medical Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 14, 2026
- Date Received
- May 18, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)