510(k) K241809
- Device
- coactiv+? Antimicrobial Wound Gel
- Applicant
- Kane Biotech, Inc.
- 510(k) number
- K241809
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-19
- Date received
- 2024-06-21
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lori Christofalos
- Address
- 290-100 Innovation Dr. Winnipeg CA R3T6G2 R3T6G2
FDA Registration Numbers#
- 3005533873
- 3004727227
- 3008132238
- 2431014
- 3008132398
- 3009109670
- 3002636527
- 1048735
- 3008396914
- 3012979524
- 1047843
- 3006784948
- 3013298431
- 1000317571
- 3005315793
- 3042953785
- 3005761322
- 3003418325
- 3007735241
- 3013671177
- 3016807311
- 3044026004
- 1038758
- 3031180770
- 2529394
- 9680143
- 3018153007
- 3013133723
- 3006498370
- 3011191255
- 3010452421
- 3020745223
- 3015309358
- 3013521734
- 9680731
- 3013478891
- 8044178
- 1066368
- 1225598
- 3009348823
- 3008750913
- 3043618351
- 3007648359
- 3012111117
- 1643817
- 3006633581
- 3019843904
- 8030673
- 3010770024
- 3003185698
- 1225532
- 3006802076
- 3015142802
- 3007048057
- 3010131715
- 3026399481
- 1649690
- 3036978602
- 3007966889
- 2031987
- 3015821396
- 2218158
- 3010610950
- 3010155648
- 3005113244
- 3007329020
- 3010419931
- 3007594734
- 3024856793
- 3010315629
- 3007502289
- 3007605720
- 1720929
- 3005941719
- 3027977504
- 1417592
- 3011987967
- 3016904853
- 1036836
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 |