Atteris Antimicrobial Skin Protectant— 510(k) K161212

Name: FDA 510(k) clearance K161212
Creator: U.S. Food and Drug Administration
Published: 2016-09-30

Substantially Equivalent

Rochal Industries, LLC

FDA 510(k) clearance K161212 for Atteris Antimicrobial Skin Protectant, Substantially Equivalent on 2016-09-30. Applicant: Rochal Industries, LLC. Device class: Unclassified.

Clearance details

Applicant: Rochal Industries, LLC
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2016-04-28
Decision date: 2016-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

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K254041 — SkinSmart Antimicrobial HydroGel2026-09-11
K261646 — Redermax® Antibacterial Wound Matrix2026-08-14
K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

More clearances from Rochal Industries, LLC

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K192527 — Rochal Antimicrobial Wound Gel2020-02-07
K182733 — Rochal Bioshield Silicone Film2019-06-27
K160192 — Atteris Antimicrobial Skin & Wound Cleanser2016-07-28
K160684 — Atteris No-Sting Skin Protectant2016-07-26

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.