Endoform Dermal Template
FDA 510(k) K260669 · Aroa Biosurgery , Ltd.
510(k) numberK260669
Submission
- Device name
- Endoform Dermal Template
- Applicant
- Aroa Biosurgery , Ltd.
Auckland, NZ - Received
- March 2, 2026
- Decision date
- June 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code KGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260652 | ColActive PlusKGN · Traditional | Covalon Technologies, Ltd. | 09/09/2026SE |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | Berkeley Advanced Biomaterials | 08/27/2026SE |
| K260596 | Collagen Wound PowderKGN · Traditional | Ventris Medical | 07/02/2026SE |
| K253521 | ECMT-100 WMDKGN · Traditional | Ecm Therapeutics, Inc. | 06/18/2026SE |
| K253204 | CatalyzeKGN · Traditional | BioTissue Holdings, Inc. | 06/05/2026SE |
| K254034 | Roosin Collagen PowderKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K253974 | Roosin Collagen DressingKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K261224 | MatriDermKGN · Special | Medskin Solutions Dr. Suwelack AG | 05/14/2026SE |
| K260532 | Derma-GideKGN · Special | Geistlich Pharma AG | 03/19/2026SE |
| K260218 | LacertaMatrixKGN · Special | Lacerta Life Sciences | 02/19/2026SE |
More from Lacerta Life Sciences
| 510(k) | Device | Decision |
|---|---|---|
| K250598 | Endoform Reconstructive Template - PLGAFTM · Traditional | 06/03/2025SE |
| K231305 | Endoform Dental MembraneNPL · Traditional | 01/23/2024SE |
| K223373 | EnivoBTA · Traditional | 04/07/2023SE |
| K200502 | Myriad ParticlesKGN · Traditional | 03/31/2021SE |
| K200413 | SymphonyKGN · Traditional | 07/29/2020SE |
| K183398 | Endoform RestellaFTM · Traditional | 04/11/2019SE |
| K181935 | Endoform Reconstructive Template - Non AbsorbableFTL · Traditional | 12/04/2018SE |
| K172318 | Endoform Silver Dermal TemplateFRO · Traditional | 11/17/2017SE |
| K171231 | Endoform Topical MatrixKGN · Traditional | 06/14/2017SE |
Questions and answers
When was Endoform Dermal Template cleared by the FDA?
Endoform Dermal Template (K260669) received a 510(k) decision of Substantially Equivalent on June 24, 2026, 114 days after the submission was received.
What is the product code of K260669?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.