Non-Absorbable Polyester Fiber Sutures

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

Generic Name

Suture, nonabsorbable, synthetic, polyester

PMA Number

N83509 ↗

FDA Product Code

GAS

Device Class

Class II

Regulation

21 CFR Part 878.5000

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S006

• Multiclip Disp. Ligating Clip Device

  Class II

  FDA 510(k) K820999 Active Cleared 13 May 1982

• Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick- Picc Peripherally Inserted Central

  Class II

  FDA 510(k) K974015 Active Cleared 18 May 1998

• Dexon 's' Polyglycolic Acid Mesh

  Class II

  FDA 510(k) K830889 Active Cleared 9 May 1983

• Polyethylene Terephthalate (Pet) Pledget

  Class II

  FDA 510(k) K953425 Active Cleared 21 Aug 1995

• Davis & Geck Needle/Sharps Counter

  Class I

  FDA 510(k) K811191 Active Cleared 27 May 1981

• Biofix* Biodegradable Fixation Rod

  Class II

  FDA 510(k) K890902 Active Cleared 3 Nov 1989

See all devices from Davis & Geck, Inc. →

• What types of surgical procedures are these polyester sutures primarily used for, and why is this material chosen for those applications?

  These non-absorbable polyester sutures are designed for tissue approximation and wound closure in general and plastic surgery procedures. Polyester is chosen because it provides long-term strength and durability, making it ideal for situations where sustained support is needed, such as in high-tension wounds or areas requiring prolonged healing. Its synthetic nature also reduces the risk of tissue reaction compared to natural fibers.

• Are these sutures intended for single-use only, and if so, how should they be stored to maintain sterility?

  Yes, these sutures are supplied in sterile, single-use packaging, ensuring they remain uncontaminated for one-time clinical use. To maintain sterility, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for specific storage conditions, as improper handling could compromise sterility.

• What does the FDA Premarket Approval (PMA) mean for these sutures, and how does it affect their use in clinical settings?

  The FDA Premarket Approval (PMA N83509) indicates that these sutures have undergone rigorous review to ensure their safety and effectiveness for their intended use in controlled clinical settings. This approval means they meet strict regulatory standards and are authorized for use in general and plastic surgery procedures, providing clinicians confidence in their reliability for tissue approximation and wound closure.

• How many different sizes or reference codes are available for these sutures, and why might a clinician need to select a specific size?

  These sutures come in multiple sizes and reference codes, as listed in the regulatory database (e.g., FEI numbers like 3005747797, 1220246, etc.). The size selection depends on the anatomical location and the specific surgical requirements—thinner sutures may be used for delicate tissues, while thicker ones provide greater tensile strength for high-stress areas. The variety ensures compatibility with different clinical needs.

• What regulatory compliance does this product adhere to, and how does that impact its manufacturing and performance standards?

  These sutures comply with FDA regulation number 878.5000, which governs the manufacturing, labeling, and performance standards for sutures. This compliance ensures consistency in quality, safety, and performance, reinforcing that each batch meets the same rigorous criteria for use in surgical procedures. Clinicians can rely on these standards when selecting sutures for patient care.