Endoform Dermal Template— 510(k) K260669
Substantially EquivalentAroa Biosurgery , Ltd.
FDA 510(k) clearance K260669 for Endoform Dermal Template, Substantially Equivalent on 2026-06-24. Applicant: Aroa Biosurgery , Ltd.. Device class: Unclassified.
Summary
Aroa Biosurgery's Endoform Dermal Template is filed under KGN, wound dressings with animal-derived materials. 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 Traditional 510(k).
Aroa filed from Auckland, New Zealand. The decision came 114 calendar days after receipt (March 2 to June 24, 2026).
Clearance details
- Applicant
- Aroa Biosurgery , Ltd.
- Product code
- Product code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auckland, NZ
Recent devices under product code KGN
view allMore clearances from Aroa Biosurgery , 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.