Vashe Skin and Wound Hydrogel
FDA 510(k) K123071 · Puricore, Inc.
510(k) numberK123071
Submission
- Device name
- Vashe Skin and Wound Hydrogel
- Applicant
- Puricore, Inc.
Malvern, PA, US - Received
- October 1, 2012
- Decision date
- January 24, 2013
- 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
| 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 |
|---|---|---|
| K141863 | Puricore Wound Hydrogel Spray DressingFRO · Traditional | 05/14/2015SE |
| K131848 | Vashe Wound Solution (4.0 Oz), (8.5 Oz & (16.0 Oz)FRO · Traditional | 03/31/2014SE |
| K123072 | Vashe Wound Therapy SolutionFRO · Traditional | 02/14/2013SE |
| K100918 | Vashe Wound Therapy System Model: 9000-0014FRO · Traditional | 08/09/2010SE |
| K093697 | Vashe Wound Therapy SolutionFRO · Traditional | 04/13/2010SE |
| K093155 | Vashe Wound Cleansing SystemFRO · Traditional | 03/01/2010SE |
| K092232 | Modification To:Vashe Wound Cleansing System, Model 9000-0014FRO · Special | 08/19/2009SE |
| K063159 | Sterilox Liquid Chemical Sterilant SystemMED · Traditional | 04/02/2007SE |
| K061689 | Aquatine Ec Endodontic CleanserKJJ · Traditional | 08/24/2006SE |
Questions and answers
When was Vashe Skin and Wound Hydrogel cleared by the FDA?
Vashe Skin and Wound Hydrogel (K123071) received a 510(k) decision of Substantially Equivalent on January 24, 2013, 115 days after the submission was received.
What is the product code of K123071?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.