Cleared Special

ProCinch, QuadCinch

K240194 · Riverpoint Medical · Orthopedic
Feb 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K240194 is an FDA 510(k) clearance for the ProCinch, QuadCinch, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on February 21, 2024, 28 days after receiving the submission on January 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K240194 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2024
Decision Date February 21, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040