DemeDIOX Absorbable Surgical Suture

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

Full name

DemeTECH DemeDIOX absorbable surgical suture

510(k) Number

K181582 ↗

FDA product code

NEW

Device class

Class II

Regulation

21 CFR Part 878.4840

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

• DemeLON

  Class IIb

  CE/MDD

• DemeSILK

  Class IIb

  CE/MDD

• DemeSORB

  Class III

  CE/MDD

• DemeCAPRONE

  Class III

  CE/MDD

• DemeSTEEL

  Class IIb

  CE/MDD

• DemeLENE

  Class IIb

  CE/MDD

See all devices from DemeTECH Corp →

• What types of surgical procedures is the DemeDIOX absorbable suture designed for, and why is it a good choice for those procedures?

  The DemeDIOX absorbable suture is specifically designed for general and plastic surgery procedures, where tissue approximation and wound closure are required. It is made from polydioxanone (PDS), a material known for its controlled absorption over time, which helps maintain wound integrity while gradually dissolving. This makes it ideal for procedures where prolonged support is needed without the need for suture removal, such as deep tissue closures or areas prone to tension.

• Is the DemeDIOX suture single-use only, and if so, how should it be stored to maintain sterility?

  Yes, the DemeDIOX suture is supplied in sterile, single-use packaging, ensuring it remains uncontaminated for one-time use only. To maintain sterility, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of moisture. Always check the expiration date on the packaging before use.

• What sizes and reference codes are available for the DemeDIOX suture, and how can I identify the correct size for my procedure?

  The DemeDIOX suture is available in multiple sizes, each corresponding to specific reference codes listed in the FDA’s OpenFDA database (e.g., 3003639970, 3013529787, etc.). The size typically correlates with the suture’s diameter and length, which are standardized for different clinical needs—such as fine tissue approximation or larger tissue gaps. Refer to the product packaging or manufacturer’s documentation to match the correct size to your procedure’s requirements, ensuring proper wound closure.

• Is the DemeDIOX suture safe to use in environments where MRI scans are performed, and if not, what alternatives should I consider?

  The DemeDIOX suture is explicitly noted as non-magnetic, meaning it does not contain metallic or ferromagnetic components that could interfere with MRI scans. However, since it is an absorbable suture, its safety in MRI environments is primarily tied to its material properties rather than magnetic susceptibility. There are no specific MRI safety restrictions mentioned, so it can generally be used in procedures where MRI compatibility is a concern. Always verify with your facility’s MRI safety protocols if unsure.

• How was the regulatory approval for the DemeDIOX suture determined, and what does this mean for its use in clinical settings?

  The DemeDIOX suture was granted FDA 510(k) clearance and complies with the Medical Device Directive (MDD), with a decision described as ‘Substantially Equivalent’ to existing devices in the market. This means the FDA determined that the suture’s design and performance meet the same regulatory standards as comparable polydioxanone sutures already in use. Clinically, this approval indicates it has undergone rigorous testing for safety and effectiveness, making it a reliable choice for general and plastic surgery applications where absorbable sutures are preferred.