510(k) K260285
K260285 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Triad Hydrophilic Wound Dresssing (1964, 2.5 oz); Triad Hydrophilic Wound Dressing (1967, 6 oz)". The FDA issued a decision of Substantially Equivalent on Oct 26, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Coloplast Corp. has 141 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 26, 2026
- Date Received
- Jan 29, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)