IWD-Gel— 510(k) K254191
Substantially EquivalentInnovaCorium, Inc.
FDA 510(k) clearance K254191 for IWD-Gel, Substantially Equivalent on 2026-04-07. Applicant: InnovaCorium, Inc.. Device class: Unclassified.
Summary
InnovaCorium's IWD-Gel is filed under product code FRO (Dressing, Wound, Drug). The record doesn't describe the gel beyond its name and that code name.
Class 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).
InnovaCorium filed from Gainesville, Florida. The decision came 105 calendar days after FDA received it (December 23, 2025 to April 7, 2026).
Clearance details
- Applicant
- InnovaCorium, Inc.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, 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.