PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
FDA 510(k) K153678 · Permeaderm, Inc.
510(k) numberK153678
Submission
- Device name
- PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
- Applicant
- Permeaderm, Inc.
Carlsbad, CA, US - Received
- December 21, 2015
- Decision date
- August 8, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
Other 510(k)s with product code FRO
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|---|---|---|---|
| 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 |
Questions and answers
When was PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove cleared by the FDA?
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove (K153678) received a 510(k) decision of Substantially Equivalent on August 8, 2016, 231 days after the submission was received.
What is the product code of K153678?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.