IWD-Gel™
FDA 510(k) clearance K254191 · decided 2026-04-07
Clearance details
- K-number
- K254191
- Device name
- IWD-Gel™
- Applicant
- InnovaCorium, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-23
- Decision date
- 2026-04-07
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
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| Bonvadis® (K261638) | Oneness Biotech Co., Ltd. | 2026-06-17 |
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| MiraChlor Antimicrobial Wound Solution (K252023) | Letus Corporation | 2026-03-25 |
| Promogran Prisma™ Collagen Matrix with ORC and Silver (K251999) | Solventum Germany GmbH | 2026-03-13 |
| LUOFUCON® Antimicrobial Wound Gel (K252028) | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| Redermax Antibacterial Wound Matrix (K251582) | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| New Day Skin Spray (K252568) | Silk Holdings, Inc. | 2026-01-23 |
| SBC1 Cream (K250890) | Sioxmed, LLC | 2026-01-12 |
| revyve® Antimicrobial Skin and Wound Cleanser (K252759) | Kane Biotech, Inc. | 2026-01-08 |
| Puracyn® Plus Antimicrobial Irrigation Solution (K251757) | Innovacyn, Inc. | 2026-01-05 |
Recalls involving this device
No recalls on record reference this clearance.