HyperSuture All Blue Extension Line— 510(k) K241376

Name: FDA 510(k) clearance K241376
Creator: U.S. Food and Drug Administration
Published: 2024-08-09

Substantially Equivalent

Threadstone, LLC

FDA 510(k) clearance K241376 for HyperSuture All Blue Extension Line, Substantially Equivalent on 2024-08-09. Applicant: Threadstone, LLC. Device class: 2.

Clearance details

Applicant: Threadstone, LLC
Product code: Product code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2024-05-15
Decision date: 2024-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millersville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAT

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K253910 — Stitch - Suture Wires and Tapes2026-08-22
K261021 — EasyWhip Family2026-07-01
K260775 — Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape2026-05-06
K254275 — HyperSuture All Green Extension Line2026-03-23
K254188 — Meniscus Versaflex2026-02-19

More clearances from Threadstone, LLC

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K242201 — HyperSuture White/Green Extension Line2025-03-27
K234079 — HyperSuture Extension Line2024-05-10
K230311 — HyperSuture2023-11-24

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.