Polyviolene Suture

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Suture, nonabsorbable, synthetic, polyester

PMA Number

N80950 ↗

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

S001

• Look Irrigating/Aspirating Cannula W/Teflon Sheath

  Class I

  FDA 510(k) K872884 Active Cleared 10 Aug 1987

• Look Irrigating Cystotomes

  Class I

  FDA 510(k) K870439 Active Cleared 20 Feb 1987

• Look Viscodissector

  Class II

  FDA 510(k) K913530 Active Cleared 21 Oct 1991

• Sterile Black Monofilament Nylon Non-Absor. Suture

  Class II

  FDA 510(k) K903029 Active Cleared 25 Oct 1990

• Ophthalmic PAO Valve

  Class II

  FDA 510(k) K882536 Active Cleared 9 Sep 1988

• Look Retrobulbar Needles

  Class I

  FDA 510(k) K870902 Active Cleared 20 Mar 1987

See all devices from Look, Inc. →

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

  The Polyviolen Suture is designed for general and plastic surgical applications, specifically for tissue approximation and ligation in soft tissues. It is a nonabsorbable, synthetic polyester suture, which means it remains in place for extended periods, making it ideal for procedures requiring long-term wound support or where delayed healing is expected. Its durability and strength are particularly beneficial in plastic surgery, where precision and stability are critical.

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

  Yes, the Polyviolen Suture is supplied in sterile form for single-use only, as indicated in the regulatory documentation. To maintain sterility, it must be stored according to standard sterile medical device protocols—typically in a sealed, unopened package in a clean, dry environment, away from direct sunlight or extreme temperatures. Always check the expiration date on the packaging before use.

• What regulatory pathway does the Polyviolen Suture follow, and what does this mean for clinicians or buyers?

  The Polyviolen Suture follows the FDA Premarket Approval (PMA) pathway, with PMA number N80950, meaning it has undergone rigorous clinical evaluation and approval before commercialization. This ensures that the device meets strict safety and effectiveness standards for its intended use in tissue approximation and ligation. Clinicians can trust its regulatory status as a Class II medical device, classified under 21 CFR 878.5000, which indicates it is well-vetted for surgical applications.

• Are there different sizes or models of the Polyviolen Suture, and if so, how would a clinician determine the appropriate one for a procedure?

  While the provided data does not specify exact sizes or models (such as suture caliber or length), the Polyviolen Suture is categorized under FEI numbers and product code GAS, which typically correspond to variations in diameter, length, or needle attachment for different surgical needs. Clinicians should refer to the product packaging or manufacturer’s documentation (Look, Inc.) to select the appropriate size based on tissue type, depth, and surgical technique—thinner sutures for delicate tissues and thicker ones for high-tension areas.