Endoform Dermal Template— 510(k) K260669

Name: FDA 510(k) clearance K260669
Creator: U.S. Food and Drug Administration
Published: 2026-06-24

Substantially Equivalent

Aroa Biosurgery , Ltd.

FDA 510(k) clearance K260669 for Endoform Dermal Template, Substantially Equivalent on 2026-06-24. Applicant: Aroa Biosurgery , Ltd.. Device class: Unclassified.

Clearance details

Applicant: Aroa Biosurgery , Ltd.
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2026-03-02
Decision date: 2026-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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K260596 — Collagen Wound Powder2026-07-02
K253521 — ECMT-100 WMD2026-06-18
K253204 — Catalyze2026-06-05
K253974 — Roosin Collagen Dressing2026-06-03

More clearances from Aroa Biosurgery , Ltd.

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K250598 — Endoform Reconstructive Template - PLGA2025-06-03
K231305 — Endoform Dental Membrane2024-01-23
K223373 — Enivo2023-04-07
K200502 — Myriad Particles2021-03-31
K200413 — Symphony2020-07-29

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.