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APTOS Threads Polypropylene Surgical Sutures

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K192953

by Aptos, LLC

Identifiers

510(k) Number
K192953 FDA 510(k)
FDA Product Code
GAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5010 FDA 510(k)
Regulation Number
878.5010 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

APTOS Threads Polypropylene Surgical Sutures are nonabsorbable, synthetic sutures made from polypropylene. These monofilament sutures are designed for general and plastic surgery applications, providing reliable tissue approximation and wound closure with minimal tissue reactivity.

The sutures are supplied in sterile, single-use packaging and are classified as Class II medical devices under FDA regulations. They are intended for use in various surgical procedures, including soft tissue repair, and are available in multiple sizes and reference codes as listed in the OpenFDA database. Compliance with FDA 510(k) clearance and MDD authorisations ensures adherence to regulatory standards for surgical sutures.

Frequently asked questions

What types of surgical procedures are these sutures primarily intended for?

APTOS Threads Polypropylene Surgical Sutures are designed for general and plastic surgery applications, specifically for soft tissue repair and wound closure. Their monofilament construction minimizes tissue reactivity, making them suitable for procedures requiring reliable tissue approximation.

Are these sutures reusable or intended for single-use only?

These sutures are supplied in sterile, single-use packaging, meaning each package is intended for one surgical procedure only. This ensures sterility and reduces the risk of contamination or infection.

How many sizes or models of APTOS Threads are available, and how can I identify them?

APTOS Threads are available in multiple sizes and models, each associated with a unique reference code listed in the OpenFDA database (e.g., 3003495548, 3038718579, etc.). These codes help identify specific suture gauges, lengths, or packaging configurations, ensuring the correct selection for your procedure.

What regulatory pathways have these sutures undergone, and what does that mean for their use?

APTOS Threads Polypropylene Surgical Sutures have undergone FDA 510(k) clearance and comply with the Medical Devices Directive (MDD). This means they meet U.S. and EU regulatory standards for safety and performance as nonabsorbable, synthetic sutures, ensuring they can be trusted for general and plastic surgery applications.

How should these sutures be stored to maintain their integrity?

Since these sutures are supplied in sterile, single-use packaging, they should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Proper storage ensures sterility and preserves the suture’s structural integrity until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aptos, LLC

Sources (2)

  • FDA 510(k) K192953 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026