Cleared Traditional

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )

K230036 · Rti Surgical, Inc. · General & Plastic Surgery
Jun 2023
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K230036 is an FDA 510(k) clearance for the Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ), a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on June 23, 2023, 178 days after receiving the submission on December 27, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K230036 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2022
Decision Date June 23, 2023
Days to Decision 178 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5000