Polypropylene Surgical Suture

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

Generic name

Suture, nonabsorbable, synthetic, polypropylene

FDA applicant

Alcon Laboratories

PMA number

P890002 ↗

FDA product code

GAW

Device class

Class II

Regulation

21 CFR Part 878.5010

Advisory committee

General, Plastic Surgery

FDA decision

APRL

• AcrySof

  Class IIb

  CE/MDD

• Systane

  Class IIb

  CE/MDR

• Cannulas and Cystitomes - Cystitomes

  Class IIa

  CE/MDR

• AIR OPTIX Night & Day AQUA

  Class IIb

  CE/MDR

• Cannulas and Cystitomes - Non-sterile, Cystitomes

  Class IIa

  CE/MDR

• AcrySof

  Class IIb

  CE/MDD

See all devices from Alcon Laboratories, Inc. →

• What types of surgical procedures is this polypropylene suture designed for, and why is it preferred in those settings?

  This polypropylene suture is designed for approximating and ligating tissues during general and plastic surgery procedures. It is preferred in these settings due to its synthetic composition, which provides durable wound closure with minimal tissue reactivity. The low reactivity helps reduce inflammation and infection risks, making it ideal for delicate or high-tension areas where long-term stability is required.

• Is this suture safe to use in MRI environments, and if not, what precautions should be taken?

  No, this polypropylene suture is not MRI-safe. Since it contains synthetic polypropylene, it may cause artifacts or heating during MRI scans, posing risks to both the patient and imaging quality. If MRI imaging is anticipated post-surgery, alternative non-MRI-safe sutures should be avoided, or the patient should be informed of the potential limitations.

• How is this suture supplied, and what should be considered regarding its sterility and single-use nature?

  This suture is supplied in sterile, single-use packaging, ensuring contamination-free use in surgical settings. Because it is designed for one-time use only, opening or reprocessing the packaging is not recommended, as it could compromise sterility and violate manufacturer guidelines. Always use a fresh, unopened package per procedure.

• What sizes or calibers are available for this suture, and how might a clinician determine the appropriate size for a specific procedure?

  This suture is available in multiple sizes, each corresponding to a specific product code listed in the regulatory records (e.g., 3003495548, 3038718579, etc.). The appropriate size depends on the tissue type, tension requirements, and surgical context. For example, finer gauges (e.g., 6-0 or 7-0) are typically used for delicate tissues like facial plastic surgery, while thicker gauges (e.g., 2-0 or 3-0) may be better suited for high-tension areas like general surgery. Consulting product documentation or manufacturer guidelines is advised to match the suture size to the clinical need.

• What storage conditions are recommended to maintain the suture’s integrity and sterility before use?

  To preserve sterility and performance, this suture should be stored in its original, unopened packaging in a cool, dry place away from direct sunlight or extreme temperatures. Avoid exposure to moisture, chemicals, or physical damage, as these factors could compromise the suture’s material integrity or sterility. Always check the expiration date on the packaging before use.