Kerecis Silicone
FDA 510(k) K213231 · Kerecis Limited
510(k) numberK213231
Submission
- Device name
- Kerecis Silicone
- Applicant
- Kerecis Limited
Isafjordur, IS - Received
- September 30, 2021
- Decision date
- June 29, 2022
- 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 |
| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
| 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 |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKGN · Special | 07/16/2025SE |
| K251844 | Kerecis SurgiBind (50241)OXH · Special | 07/15/2025SE |
| K243843 | Tendon Protect (50242)OWY · Traditional | 06/04/2025SE |
| K241080 | Kerecis Parvus (50207)KGN · Traditional | 08/21/2024SE |
| K213904 | Kerecis OralNPL · Traditional | 09/30/2022SE |
| K202430 | Kerecis ReconstructOXH · Traditional | 05/02/2021SE |
| K192612 | Kerecis Gingiva GraftNPL · Traditional | 11/13/2020SE |
| K190528 | MariGen Wound ExtraKGN · Traditional | 07/10/2019SE |
| K153364 | Kerecis SecureMeshOXE · Traditional | 08/19/2016SE |
| K132343 | Marigen Wound DressingKGN · Traditional | 10/23/2013SE |
Questions and answers
When was Kerecis Silicone cleared by the FDA?
Kerecis Silicone (K213231) received a 510(k) decision of Substantially Equivalent on June 29, 2022, 272 days after the submission was received.
What is the product code of K213231?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.