510(k) K252759
- Device
- revyve® Antimicrobial Skin and Wound Cleanser
- Applicant
- Kane Biotech, Inc.
- 510(k) number
- K252759
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-08
- Date received
- 2025-08-29
- 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
- Valerie Acosta
- Address
- 190 - 100 Innovation Dr. Winnipeg CA R3T 6G2 R3T 6G2
FDA Registration Numbers#
- 1929833
- 1423537
- 3011987967
- 3017297225
- 3012535730
- 3009344179
- 3015200795
- 3033530347
- 3006506075
- 3015309358
- 3031841433
- 1423395
- 3005920706
- 3010400367
- 3007502289
- 1018120
- 8030128
- 1047843
- 3030691709
- 9615014
- 1054241
- 2245304
- 3003617485
- 3009756327
- 3016116741
- 3017633586
- 1648579
- 9610825
- 3013035118
- 1220477
- 1417519
- 3036978602
- 3043622938
- 3010160527
- 1036836
- 3006606901
- 3012973796
- 3014258951
- 2083373
- 3013671177
- 1061124
- 1038758
- 1420032
- 3015077448
- 3018167761
- 3017509841
- 3015821396
- 3009109670
- 3013521734
- 3010288357
- 3016904853
- 2320762
- 3002807310
- 3004713654
- 3010034780
- 1424263
- 3004125670
- 1025483
- 3015219237
- 9618003
- 2245590
- 3007966889
- 3003524577
- 9610694
- 3007735241
- 3003185698
- 1480288
- 3034456223
- 9615662
- 2032098
- 3017552041
- 1531062
- 3005669815
- 3010610950
- 3009973323
- 3031168520
- 3014635301
- 3003755939
- 3004512585
Source Documents#
Other 510(k) Records For Product Code FRO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025-10-10 |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | 2025-08-27 |
| K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025-07-22 |