Nonabsorbable Surg. Sutures, Braided Silk

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Suture, nonabsorbable, silk

PMA Number

N84348 ↗

FDA Product Code

GAP

Device Class

Class II

Regulation

21 CFR Part 878.5030

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S001

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• Pleur-Evac Cardiotomy Reservoir # Cr-9400 & 9400F

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See all devices from Deknatel, Inc. →

• What types of surgical procedures is this braided silk suture intended for, and why is it a good choice for those procedures?

  This braided silk suture is specifically designed for use in general and plastic surgery procedures to approximate (bring together) and ligate (tie off) tissues. It is a good choice because its nonabsorbable nature provides durable closure over time, maintaining tensile strength and resistance to degradation, which is critical for long-term wound stability in these types of surgeries.

• How is this suture supplied, and what precautions should be taken when handling it?

  The suture is supplied in sterile, single-use packaging, ensuring it is ready for immediate intraoperative use without additional sterilization. Since it is not MRI-safe, it must be handled with sterile technique to prevent contamination, and it should only be used once before disposal to maintain sterility and safety.

• Are there multiple sizes or lengths available for this suture, and how does this variety benefit clinicians?

  Yes, this braided silk suture is available in various sizes and lengths, allowing clinicians to select the most appropriate option for specific surgical needs. This variety ensures flexibility in handling different tissue types, depths, and anatomical locations, improving precision and effectiveness during procedures.

• What regulatory pathway does this suture follow, and what does that mean for its use in clinical settings?

  This suture follows the FDA Premarket Approval (PMA) pathway, classified as a Class II device under regulation number 878.5030. This means it has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use in approximating and ligating tissues, providing clinicians with confidence in its reliability for general and plastic surgery procedures.

• Is this suture reusable, and if not, what are the implications for inventory and cost management?

  No, this suture is intended for single-use only, as indicated by its sterile packaging. This design ensures patient safety by preventing cross-contamination and reduces the risk of infection. Clinically, this means hospitals and surgical centers must account for single-use costs and manage inventory carefully to avoid shortages during procedures.