REXSIN

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

510(k) Number

K200392 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Rexmono, Pdrex

  Class II

  FDA 510(k) K173779 Active Cleared 12 Mar 2018

• Rexlon, Rexsil

  Class II

  FDA 510(k) K161633 Active Cleared 2 Mar 2017

• Crylrex

  Class II

  FDA 510(k) K161629 Active Cleared 10 Feb 2017

• Rexlene

  Class II

  FDA 510(k) K173747 Active Cleared 21 Dec 2018

• What is REXSIN used for in surgical procedures?

  REXSIN is an absorbable suture made from polyglycolic acid (PGA), specifically designed for soft tissue approximation and ligation. It is intended for use in general and plastic surgery procedures, excluding cardiovascular or neural tissue applications. The absorbable nature of PGA allows the suture to gradually dissolve within the body over time, reducing the need for suture removal.

• Is REXSIN supplied with or without a needle?

  REXSIN is available in variants that may be supplied either with or without a needle, depending on the specific model. This flexibility allows clinicians to choose the variant that best fits their surgical requirements, whether they need a pre-attached needle for convenience or a needleless option for specific techniques.

• How should REXSIN be stored to maintain sterility?

  REXSIN must be stored according to the manufacturer’s guidelines to ensure sterility and integrity. Since it is intended for single-use in sterile surgical settings, it should be kept in its original, unopened packaging until use. Proper storage conditions, such as avoiding extreme temperatures or contamination, are critical to maintaining its effectiveness and compliance with sterile surgical protocols.

• Is REXSIN intended for reuse, or is it single-use only?

  REXSIN is explicitly designed for single-use only. As an absorbable suture intended for sterile surgical environments, reuse is not recommended or approved. Single-use ensures patient safety by preventing cross-contamination and maintaining the device’s sterility and performance standards.

• What regulatory approval does REXSIN have for use in the U.S.?

  REXSIN is regulated under the FDA’s 510(k) clearance process and holds a clearance number (K200392) as a Class 2 device under product code GAM. This classification confirms that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for the intended use in soft tissue approximation and ligation within general and plastic surgery.