Nexodyn AOS Wound Care Solution— 510(k) K151168

Name: FDA 510(k) clearance K151168
Creator: U.S. Food and Drug Administration
Published: 2015-12-22

Substantially Equivalent

Apr Applied Pharma Research SA

FDA 510(k) clearance K151168 for Nexodyn AOS Wound Care Solution, Substantially Equivalent on 2015-12-22. Applicant: Apr Applied Pharma Research SA. Device class: Unclassified.

Clearance details

Applicant: Apr Applied Pharma Research SA
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2015-05-01
Decision date: 2015-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Balerna, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

view all

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

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.