Fortaderm Wound Dressing
FDA 510(k) K011026 · Organogenesis, Inc.
510(k) numberK011026
Submission
- Device name
- Fortaderm Wound Dressing
- Applicant
- Organogenesis, Inc.
Canton, MA, US - Received
- April 4, 2001
- Decision date
- June 13, 2001
- 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 |
|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix)KGN · Traditional | 05/02/2023SE |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ)KGN · Traditional | 07/01/2022SE |
| K071555 | Fortagen Oral MembraneNPL · Traditional | 08/30/2007SE |
| K051647 | Fortaderm Antimicrobial Wound DressingFRO · Traditional | 11/08/2005SE |
| K042809 | CuffpatchFTM · Traditional | 11/02/2004SE |
| K021107 | Fortaflex Surgical SlingFTM · Traditional | 05/15/2002SE |
| K021105 | Fortaflex Surgical MeshFTM · Traditional | 05/10/2002SE |
| K020049 | Fortaflex Surgical MeshFTM · Traditional | 03/18/2002SE |
| K011025 | Fortaflex Surgical MeshFTM · Traditional | 08/24/2001SE |
| K011027 | Fortaflex Surgical SlingFTM · Traditional | 05/30/2001SE |
Questions and answers
When was Fortaderm Wound Dressing cleared by the FDA?
Fortaderm Wound Dressing (K011026) received a 510(k) decision of Substantially Equivalent on June 13, 2001, 70 days after the submission was received.
What is the product code of K011026?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.