Cleared Traditional

HyperSuture White/Green Extension Line

K242201 · Threadstone, LLC · General & Plastic Surgery
Mar 2025
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K242201 is an FDA 510(k) clearance for the HyperSuture White/Green Extension Line, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Threadstone, LLC (Millersville, US). The FDA issued a Cleared decision on March 27, 2025, 244 days after receiving the submission on July 26, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K242201 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2024
Decision Date March 27, 2025
Days to Decision 244 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