Colactive Collagen Wound Dressing
FDA 510(k) K050177 · Covalontechnologies, Inc.
510(k) numberK050177
Submission
- Device name
- Colactive Collagen Wound Dressing
- Applicant
- Covalontechnologies, Inc.
Largo, FL, US - Received
- January 26, 2005
- Decision date
- April 27, 2005
- 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 |
|---|---|---|
| K163556 | MediClear PreOpKKX · Traditional | 09/14/2017SE |
| K150550 | SilverCoat Silicone Foley CatheterEZL · Traditional | 11/24/2015SE |
| K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverFRO · Traditional | 08/13/2012SE |
| K112549 | IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverFRO · Traditional | 05/04/2012SE |
| K043296 | Colactive AG Collagen with Silver Antimicrobial DressingFRO · Traditional | 06/06/2005SE |
Questions and answers
When was Colactive Collagen Wound Dressing cleared by the FDA?
Colactive Collagen Wound Dressing (K050177) received a 510(k) decision of Substantially Equivalent on April 27, 2005, 91 days after the submission was received.
What is the product code of K050177?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.