510(k) K260285
- Device
- Triad Hydrophilic Wound Dresssing (1964, 2.5 oz); Triad Hydrophilic Wound Dressing (1967, 6 oz)
- Applicant
- Coloplast Corp.
- 510(k) number
- K260285
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-26
- Date received
- 2026-01-29
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Preeti Jain
- Address
- 1601 W. River Rd. Minneapolis MN US 55411 55411
FDA Registration Numbers#
- 3003185698
- 1066368
- 3029971427
- 9615662
- 3006052875
- 3004932373
- 3010315629
- 3009317711
- 1929833
- 3031757047
- 2135339
- 3005113244
- 3004748528
- 3007048057
- 3007120504
- 3043226252
- 3007966889
- 3014146451
- 3009176340
- 3005669815
- 3016450032
- 3031180770
- 1220246
- 2320762
- 1720929
- 3032911850
- 3004799623
- 3005706359
- 3007662962
- 3013764800
- 3044026004
- 3031841433
- 3006633581
- 3010178296
- 3024856793
- 1423537
- 1450662
- 3038550164
- 3009655869
- 3027590916
- 3030229896
- 1038758
- 1055236
- 3004496953
- 3007289408
- 3016601021
- 3012494290
- 8043792
- 3009344179
- 9680731
- 1225532
- 3002636527
- 1061124
- 8043991
- 3031168520
- 3009610508
- 3010395155
- 3014635301
- 1417592
- 3009504230
- 3009973323
- 1319660
- 3010132111
- 3004018264
- 3006506075
- 3038179167
- 1043549
- 3006606901
- 3012448339
- 3025431504
- 3010034780
- 1048735
- 3005004019
- 3005369309
- 3016807311
- 3005674466
- 3009756327
- 3004681519
- 3011689956
Source Documents#
Other 510(k) Records For Product Code FRO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | 2026-09-22 |
| K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | 2026-09-11 |
| 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 |