Redermax® Antibacterial Wound Matrix— 510(k) K261646
Substantially EquivalentBeijing Kreate Medical Co., Ltd.
FDA 510(k) clearance K261646 for Redermax® Antibacterial Wound Matrix, Substantially Equivalent on 2026-08-14. Applicant: Beijing Kreate Medical Co., Ltd.. Device class: Unclassified.
Summary
Beijing Kreate Medical's Redermax Antibacterial Wound Matrix is filed under product code FRO, drug wound dressings. The record gives no sizes or model numbers.
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 Traditional 510(k).
Kreate filed from Beijing, China. The decision came 88 calendar days after receipt (May 18 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Beijing Kreate Medical Co., Ltd.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code FRO
view allMore clearances from Beijing Kreate Medical 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.