510(k) K262677

Iconix Knotless T by Riverpoint Medical — Product Code MBI

K262677 is an FDA 510(k) premarket notification submitted by Riverpoint Medical for the device "Iconix Knotless T". The FDA issued a decision of Substantially Equivalent on August 27, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Riverpoint Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2026
Date Received
July 30, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type