Microdacyn Wound Irrigation Solution— 510(k) K261023
Substantially EquivalentSonoma Pharmaceuticals, Inc.
FDA 510(k) clearance K261023 for Microdacyn Wound Irrigation Solution, Substantially Equivalent on 2026-06-24. Applicant: Sonoma Pharmaceuticals, Inc.. Device class: Unclassified.
Summary
Sonoma Pharmaceuticals' Microdacyn Wound Irrigation Solution is filed under FRO, drug wound dressings. The record doesn't give the solution's ingredients.
The device class is listed as U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).
Sonoma filed from Boulder, Colorado. Review took 86 calendar days (March 30 to June 24, 2026).
Clearance details
- Applicant
- Sonoma Pharmaceuticals, Inc.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Recent devices under product code FRO
view allMore clearances from Sonoma Pharmaceuticals, Inc.
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . 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.