K254191
- 510(k) number
- K254191
- Device name
- IWD-Gel
- Applicant
- InnovaCorium, Inc. FL · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2026-04-07
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254191.pdf
Official FDA record: K254191
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.