Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
FDA 510(k) clearance K222740 · decided 2024-10-21
Clearance details
- K-number
- K222740
- Device name
- Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
- Applicant
- Speciality Fibres and Materials, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-09
- Decision date
- 2024-10-21
- Days to decision
- 773 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Coventry, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Microdacyn Wound Irrigation Solution (K261023) | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
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| Bonvadis® (K261638) | Oneness Biotech Co., Ltd. | 2026-06-17 |
| StatSeal Disc (K254073) | Merit Medical Systems, Inc. | 2026-05-13 |
| IWD-Gel™ (K254191) | InnovaCorium, Inc. | 2026-04-07 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.