← Back to catalogue

Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K143582

by RESORBA Medical GmbH

Identifiers

510(k) Number
K143582 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)

This device is a nonabsorbable synthetic suture made from materials including polypropylene, PVDF, silk, polyester, polyamide, and stainless steel. It is classified as a suture for general and plastic surgery applications, providing mechanical support to wound sites by holding tissue edges together to facilitate healing.

It is supplied for use in clinical settings such as the operating room by surgeons. The device received FDA 510(k) clearance under K143582, with product code GAW and regulation number 878.5010, and was determined to be substantially equivalent to a legally marketed device.

Frequently asked questions

What is the MOPYLEN suture made of and what is it used for?

The MOPYLEN suture is a nonabsorbable synthetic suture made from materials including polypropylene, PVDF, silk, polyester, polyamide, and stainless steel. It is designed for general and plastic surgery applications, providing mechanical support to wound sites by holding tissue edges together to facilitate healing.

How is the MOPYLEN suture supplied and in what clinical settings is it used?

The MOPYLEN suture is supplied for use in clinical settings such as operating rooms by surgeons. It comes in various materials including polypropylene, PVDF, silk, polyester, polyamide, and stainless steel to meet different surgical requirements.

What is the regulatory status of the MOPYLEN suture?

The MOPYLEN suture received FDA 510(k) clearance under K143582, with product code GAW and regulation number 878.5010. It was determined to be substantially equivalent to a legally marketed device for general and plastic surgery applications.

Is the MOPYLEN suture single-use or reusable?

The device data does not specify whether the MOPYLEN suture is single-use or reusable. As a medical suture, it would typically be used once per procedure to maintain sterility and prevent infection, but the specific usage instructions should be referenced from the product's labeling or manufacturer's instructions.

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. Sources consulted: Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo ..., MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON… - FDA.report, RESORBA Medical GmbH FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
RESORBA Medical GmbH

Sources (1)

  • FDA 510(k) K143582 24 fields · synced Sep 26, 2026