ColActive Plus— 510(k) K260652
Substantially EquivalentCovalon Technologies, Ltd.
FDA 510(k) clearance K260652 for ColActive Plus, Substantially Equivalent on 2026-09-09. Applicant: Covalon Technologies, Ltd.. Device class: Unclassified.
Summary
ColActive Plus is from Covalon Technologies, Ltd., filed under product code KGN (Wound Dressing With Animal-Derived Material(S)). The record doesn't describe the dressing beyond its name and code.
Class U, with no regulation number. The classification panel is listed as Unknown, and the General, Plastic Surgery review panel handled it as a Traditional 510(k). The decision was Substantially Equivalent.
Covalon filed from Mississauga, Canada. The decision came 194 calendar days after FDA received it (February 27 to September 9, 2026).
Clearance details
- Applicant
- Covalon Technologies, Ltd.
- Product code
- Product code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
Recent devices under product code KGN
view allMore clearances from Covalon Technologies, Ltd.
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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.