Dermaphylyx Hydrocolloid Wound Dressing, Healian Hydrocolloid Wound Dressing
FDA 510(k) K990891 · Dermaphylyx, Inc.
510(k) numberK990891
Submission
- Device name
- Dermaphylyx Hydrocolloid Wound Dressing, Healian Hydrocolloid Wound Dressing
- Applicant
- Dermaphylyx, Inc.
Arvada, CO, US - Received
- March 17, 1999
- Decision date
- May 27, 1999
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
Other 510(k)s with product code FRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254041 | SkinSmart Antimicrobial HydroGelFRO · Traditional | Magic Science Supply, LLC | 09/11/2026SE |
| K261646 | Redermax® Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 08/14/2026SE |
| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
| K261023 | Microdacyn Wound Irrigation SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 06/24/2026SE |
| K251929 | SilverCeuticals® Antimicrobial Wound GelFRO · Traditional | Silverceuticals, Inc. | 06/24/2026SE |
| K261638 | Bonvadis®FRO · Special | Oneness Biotech Co., Ltd. | 06/17/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | Merit Medical Systems, Inc. | 05/13/2026SE |
| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
| K251999 | Promogran Prisma Collagen Matrix with ORC and SilverFRO · Traditional | Solventum Germany GmbH | 03/13/2026SE |
More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | 09/14/1999SE |
| K991920 | Dermaphylyx Hydrophilic Foam Wound DressingKMF · Traditional | 08/12/1999SE |
| K991933 | Dermaphylyx Foam Island DressingKMF · Traditional | 07/30/1999SE |
| K991609 | Dermaphylyx Super Absorbent Fiber DressingKMF · Traditional | 07/20/1999SE |
| K991608 | Dermaphylyx Calcium Alginate Wound DressingKMF · Traditional | 07/20/1999SE |
| K991061 | Dermaphylyx Calcium Alginate Wound DressingNAE · Traditional | 06/28/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | 03/25/1999SE |
Questions and answers
When was Dermaphylyx Hydrocolloid Wound Dressing, Healian Hydrocolloid Wound Dressing cleared by the FDA?
Dermaphylyx Hydrocolloid Wound Dressing, Healian Hydrocolloid Wound Dressing (K990891) received a 510(k) decision of Substantially Equivalent for Some Indications on May 27, 1999, 71 days after the submission was received.
What is the product code of K990891?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.