510(k) K254041
- Device
- SkinSmart Antimicrobial HydroGel
- Applicant
- Magic Science Supply, LLC
- 510(k) number
- K254041
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-11
- Date received
- 2025-12-16
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Eoin Croke
- Address
- 5555 W 78th St. Suite M Edina MN US 55439 55439
FDA Registration Numbers#
- 3019843904
- 3011689956
- 3017107376
- 3010400367
- 3001124136
- 1221816
- 3038179167
- 3027815
- 9681630
- 3043226252
- 3019543072
- 3017633586
- 2435946
- 3031180770
- 1220477
- 1225532
- 3005315793
- 3011238790
- 3013133723
- 3016450032
- 3038637162
- 3015077448
- 3007289408
- 3010131578
- 3005621808
- 3024856793
- 3010034780
- 3012448339
- 1417519
- 1450662
- 3045857302
- 3012535730
- 3013557562
- 3008806809
- 3036978602
- 3017396949
- 3014312726
- 3015422337
- 1061927
- 1424263
- 3009701308
- 3009171251
- 3030625176
- 3016851379
- 3016603542
- 3005488444
- 3010288357
- 3042272797
- 2135339
- 1645368
- 3038356900
- 3004496953
- 1417411
- 1720929
- 1419520
- 1000317571
- 1036836
- 1038758
- 2431014
- 3029971427
- 3003775072
- 3002807314
- 3003185698
- 3005941719
- 3004748528
- 3014258951
- 9680143
- 1929833
- 3008562678
- 3012481754
- 9614157
- 9710608
- 1018120
- 3011191255
- 3010610560
- 3031841433
- 3018153007
- 3007187674
- 3007536356
Source Documents#
Other 510(k) Records For Product Code FRO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-08-14 |
| K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | 2026-08-11 |
| 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 |