Surgilene Suture, Nonabsorbable, Synthetic, Polyethylene

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Surgilene

Generic Name

Suture, nonabsorbable, synthetic, polyethylene

PMA Number

N17825 ↗

FDA Product Code

GAT

Device Class

Class II

Regulation

21 CFR Part 878.5000

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S001

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• What types of surgical procedures is the Surgilene Suture intended for, and why is it considered suitable for those uses?

  The Surgilene Suture is designed for general and plastic surgical procedures, specifically to approximate (close together) and ligate (tie off) soft tissues during invasive surgeries. It is made from polyethylene, a nonabsorbable synthetic material, which provides long-term strength and stability in tissues, making it ideal for procedures requiring durable wound closure or vascular control.

• Is the Surgilene Suture meant for single-use only, and if so, how should it be stored to ensure sterility?

  Yes, the Surgilene Suture is supplied in sterile, single-use packaging, meaning it should only be used once and then discarded. To maintain sterility and integrity, it must be stored according to the manufacturer’s guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

• What regulatory pathway does the Surgilene Suture follow, and what does this mean for its use in clinical settings?

  The Surgilene Suture follows the FDA Premarket Approval (PMA) pathway, indicated by PMA Number N17825. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended uses in controlled clinical settings, such as operating rooms, where sterile conditions are maintained.

• Are there different sizes available for the Surgilene Suture, and why might a clinician choose one size over another?

  Yes, the Surgilene Suture is available in various sizes, though the exact range isn’t specified in the data. The choice of size depends on the surgical procedure and tissue type—thinner sutures (e.g., smaller gauge) are often used for delicate tissues like skin or nerves, while thicker sutures may be preferred for stronger tissues like tendons or ligaments to ensure secure approximation.