Plain Gut Sterile Absorbable Sutures

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Suture, absorbable, natural

PMA Number

N83038 ↗

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

S014

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• What types of surgical procedures are these sutures commonly used for, and why are they preferred in those settings?

  These Plain Gut Sterile Absorbable Sutures are primarily used for soft tissue approximation and ligation in general and ophthalmic surgical procedures. They are preferred because their natural collagen composition allows them to biodegrade over time within the body, eliminating the need for suture removal. This makes them ideal for delicate tissues where leaving a permanent suture could cause irritation or complications.

• Are these sutures reusable, or are they intended for single-use only? How does this affect their storage and handling?

  These sutures are explicitly intended for single-use only in controlled surgical environments. Because they are sterile and designed to maintain integrity only for one procedure, proper storage according to manufacturer guidelines is critical to preserve sterility and prevent contamination. Improper reuse could compromise patient safety and violate regulatory compliance.

• How are these sutures packaged and preserved for sterility before use?

  The sutures are supplied sterile in a solution of 87% isopropanol, 12% water, and 1% triethanolamine, which helps maintain their sterility and integrity. The packaging is designed to protect them from environmental contamination until the moment of use. Always follow the manufacturer’s storage instructions to ensure the solution remains effective and the sutures remain uncontaminated.

• What regulatory pathway was followed for FDA authorization, and what does this mean for clinicians or buyers?

  These sutures were authorized via a Premarket Approval (PMA) application (N83038) with subsequent supplements (S016), meaning they underwent rigorous clinical evaluation to demonstrate safety and effectiveness. Clinicians and buyers can rely on this pathway as evidence of thorough regulatory scrutiny, ensuring the sutures meet stringent standards for absorbable natural sutures. The PMA classification also indicates they are Class II devices, subject to ongoing compliance monitoring.

• What sizes or models are available, and how might a clinician choose the right one for a procedure?

  While the exact sizes or models aren’t detailed in the provided data, these sutures are categorized under product code GAL and are listed under OpenFDA’s