510(k) K222740
- Device
- 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.
- 510(k) number
- K222740
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-21
- Date received
- 2022-09-09
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nyerngoor Korda Hewitt
- Address
- Galaxy House Binley Industrial Estate, 31 Herald Way Coventry GB CV6 5SF CV6 5SF
FDA Registration Numbers#
- 3015282703
- 1000317571
- 2245304
- 1047843
- 3011862887
- 1038758
- 9680143
- 3005706359
- 3014421917
- 3006498370
- 3008562678
- 2083373
- 3012448339
- 3005818605
- 3016116741
- 3009167225
- 3030067857
- 1055236
- 1222747
- 3010034780
- 3036978602
- 2135152
- 1319660
- 3015276780
- 3015309358
- 3024856793
- 9614157
- 2031987
- 3015422337
- 3010824458
- 3004637474
- 2124143
- 3038624837
- 3013478891
- 3014635301
- 3003477135
- 2032098
- 1417519
- 9616088
- 1054241
- 1650927
- 3005460813
- 1043549
- 3007966889
- 3000215556
- 3002807310
- 8030128
- 3011089435
- 3002636527
- 3009750086
- 3009171251
- 3008502431
- 3010131578
- 3013035118
- 3010315629
- 3004170064
- 3044026004
- 1064858
- 1649690
- 2135339
- 1417592
- 3037918935
- 3007605720
- 3003636207
- 3042366049
- 3010363503
- 3015077448
- 3002807315
- 1061124
- 3006506075
- 3008132238
- 3009655869
- 3010452421
- 3018167761
- 3018153007
- 3023113877
- 3007007790
- 3005533873
- 3004681519
Source Documents#
Other 510(k) Records For Product Code FRO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026-06-24 |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026-06-17 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |