Deklene Suture, Nonabsorbable, Synthetic, Polyethylene

No FDA recalls on record, checked 22 Oct 2026.

Full name

Deklene(Tm)

Generic Name

Suture, nonabsorbable, synthetic, polyethylene

PMA Number

P810028 ↗

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

S003

• Pleur-Evac Chest Drainage Systems

  Class II

  FDA 510(k) K905768 Active Cleared 11 Feb 1991

• Deknatel Trocar Catheter

  Class II

  FDA 510(k) K873525 Active Cleared 2 Nov 1987

• Pleur-Evac(R) Adult/Pedi Dual Coll Chest Drain Sys

  Class II

  FDA 510(k) K924337 Active Cleared 28 Jul 1993

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

  Class II

  FDA 510(k) K926338 Active Cleared 26 Jul 1994

• Pleur-Evac-A-7000--Adult/Pedi Chest Drainage Syst

  Class II

  FDA 510(k) K882223 Active Cleared 16 Aug 1988

• Deknatel Temporary Cardiac Pacing Wire

  Class II

  FDA 510(k) K873728 Active Cleared 3 Nov 1987

See all devices from Deknatel, Inc. →

• What types of surgical procedures is the Deklene™ Suture specifically designed for, and why is it considered suitable for long-term use?

  The Deklene™ Suture is designed for general and plastic surgical applications, where it can be used to ligate vessels, approximate tissues, or close wounds. It is made from nonabsorbable, synthetic polyethylene, which means it remains intact in the body for extended periods, providing long-term support where durable wound closure or tissue reinforcement is required.

• Is the Deklene™ Suture meant for reuse in multiple procedures, or is it intended for single-use only?

  The Deklene™ Suture is explicitly supplied as a sterile, single-use product. This ensures patient safety by preventing contamination or degradation from repeated sterilization processes, which is critical in surgical settings where sterility is non-negotiable.

• How should the Deklene™ Suture be stored, and what precautions should be taken to maintain its sterility?

  The Deklene™ Suture must be stored and handled according to standard sterile surgical practices. Since it is a sterile, single-use product, it should remain in its original packaging until immediately before use to prevent contamination. Proper storage conditions, such as avoiding extreme temperatures or moisture, are essential to preserve its integrity.

• What regulatory pathway does the Deklene™ Suture follow, and how does this affect its availability or use?

  The Deklene™ Suture follows the FDA Premarket Approval (PMA) pathway, with PMA number P810028. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended surgical uses. Clinicians and buyers should confirm local regulatory compliance before use, as PMA approval ensures the device meets stringent standards for nonabsorbable sutures.