510(k) K231163

HS Fiber Sutures by Riverpoint Medical — Product Code GAT

K231163 is an FDA 510(k) premarket notification submitted by Riverpoint Medical for the device "HS Fiber Sutures". The FDA issued a decision of Substantially Equivalent on January 5, 2024. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Riverpoint Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2024
Date Received
April 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type