510(k) K260285

Triad Hydrophilic Wound Dresssing (1964, 2.5 oz); Triad Hydrophilic Wound Dressing (1967, 6 oz) by Coloplast Corp. — Product Code FRO

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)

Source: FDA 510(k) database entry for K260285. Report a data issue: hello@regdatalab.com.