SilverCeuticals® Antimicrobial Wound Gel— 510(k) K251929
Substantially EquivalentSilverceuticals, Inc.
FDA 510(k) clearance K251929 for SilverCeuticals® Antimicrobial Wound Gel, Substantially Equivalent on 2026-06-24. Applicant: Silverceuticals, Inc.. Device class: Unclassified.
Summary
SilverCeuticals Antimicrobial Wound Gel from Silverceuticals is filed under FRO, drug wound dressings. The antimicrobial label comes from the device name; the record doesn't describe the gel'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).
Silverceuticals filed from Lindon, Utah. Review took 366 calendar days (June 23, 2025 to June 24, 2026).
Clearance details
- Applicant
- Silverceuticals, Inc.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lindon, UT, US
Recent devices under product code FRO
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.