Atteris Antimicrobial Skin Protectant
FDA 510(k) K161212 · Rochal Industries, LLC
510(k) numberK161212
Submission
- Device name
- Atteris Antimicrobial Skin Protectant
- Applicant
- Rochal Industries, LLC
San Antonio, TX, US - Received
- April 28, 2016
- Decision date
- September 30, 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
| 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 |
|---|---|---|
| K192527 | Rochal Antimicrobial Wound GelFRO · Traditional | 02/07/2020SE |
| K182733 | Rochal Bioshield Silicone FilmKMF · Traditional | 06/27/2019SE |
| K160192 | Atteris Antimicrobial Skin & Wound CleanserFRO · Traditional | 07/28/2016SE |
| K160684 | Atteris No-Sting Skin ProtectantKMF · Traditional | 07/26/2016SE |
Questions and answers
When was Atteris Antimicrobial Skin Protectant cleared by the FDA?
Atteris Antimicrobial Skin Protectant (K161212) received a 510(k) decision of Substantially Equivalent on September 30, 2016, 155 days after the submission was received.
What is the product code of K161212?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.