Cleared Traditional

HyperSuture All Blue Extension Line

K241376 · Threadstone, LLC · General & Plastic Surgery
Aug 2024
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K241376 is an FDA 510(k) clearance for the HyperSuture All Blue 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 August 9, 2024, 86 days after receiving the submission on May 15, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K241376 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2024
Decision Date August 09, 2024
Days to Decision 86 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