510(k) K244025

Argo Knotless GENESYS Anchor by Conmed Corporation — Product Code MBI

K244025 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "Argo Knotless GENESYS Anchor". The FDA issued a decision of Substantially Equivalent on January 28, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Conmed Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2025
Date Received
December 27, 2024
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