510(k) K261023
- Device
- Microdacyn Wound Irrigation Solution
- Applicant
- Sonoma Pharmaceuticals, Inc.
- 510(k) number
- K261023
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-24
- Date received
- 2026-03-30
- 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
- Arturo Angel
- Address
- 5445 Conestoga Ct. Suite 150 Boulder CO US 80301 80301
FDA Registration Numbers#
- 1648579
- 1424263
- 3000215556
- 3039435289
- 3005694677
- 3014635301
- 3003622638
- 8043991
- 3010178296
- 3009701308
- 3010770024
- 3025697678
- 3022754162
- 3011689956
- 3013521734
- 9615662
- 3009461428
- 1319660
- 3015077448
- 3014579161
- 3010407203
- 3006218807
- 3006498370
- 3007329020
- 3004125670
- 2246552
- 3005669815
- 3006405073
- 2124143
- 1480288
- 3004080548
- 3009504230
- 1036836
- 1055236
- 3017552041
- 3011210302
- 3045857302
- 3015422337
- 1720929
- 3027529701
- 1064858
- 2431014
- 1423537
- 3003524577
- 3005533873
- 3004950768
- 1526711
- 3009988302
- 8043792
- 3002636527
- 3004681519
- 3014421917
- 3008808082
- 3006052875
- 3001186500
- 3003617485
- 3005941719
- 3003775072
- 3004530184
- 8043484
- 1819174
- 3027815
- 1831301
- 3012448339
- 3006506075
- 3006621348
- 3015547002
- 9680091
- 1018120
- 2320762
- 2953359
- 3007966889
- 3032911850
- 3004122598
- 3009750086
- 1043549
- 3015200795
- 2245590
- 3003418325
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 |
| 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 |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |