Plain Gut Sutures

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Plain Gut

Generic Name

Suture, absorbable, natural

PMA Number

N84380 ↗

FDA Product Code

GAL

Device Class

Class II

Regulation

21 CFR Part 878.4830

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S002

• 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. →

• Are Plain Gut Sutures from Deknatel reusable or intended for single-use only?

  Plain Gut Sutures from Deknatel are supplied in sterile, single-use packaging. This design ensures each package is intended for one surgical procedure only, maintaining sterility and preventing cross-contamination between patients.

• What types of surgical procedures are these sutures commonly used for?

  These sutures are designed for soft tissue approximation and ligation, making them suitable for general and plastic surgery settings. Their absorbable, natural composition is ideal for procedures where sutures need to dissolve over time after performing their function, such as wound closure or tissue repair.

• How do I determine the correct size or length of Plain Gut Sutures for my procedure?

  The sutures come in multiple sizes and lengths, as indicated by the registration numbers listed in the data. These variations ensure compatibility with different surgical needs, so you can select the appropriate size based on the specific requirements of your procedure—consult the product documentation or manufacturer’s guidelines for exact sizing details.

• What is the regulatory pathway for Plain Gut Sutures, and how does it affect their use?

  Plain Gut Sutures from Deknatel have received Premarket Approval (PMA) under FDA regulations, classified as a Class II device with product code GAL. This approval ensures they meet stringent safety and effectiveness standards for use in soft tissue approximation and ligation, though the approval itself does not dictate clinical indications—only the manufacturer’s intended surgical applications.

• How should Plain Gut Sutures be stored to maintain their sterility and integrity?

  Since they are supplied in sterile, single-use packaging, these sutures should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s storage instructions to preserve sterility and prevent degradation before use.