← Back to catalogue

LSI Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040232

by Lsi Solutions

Identifiers

510(k) Number
K040232 FDA 510(k)
FDA Product Code
GAT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5000 FDA 510(k)
Regulation Number
878.5000 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sew-Right SR-5R, Model 020999, is a suture placement device classified under Suture, Nonabsorbable, Synthetic, Polyethylene (Product Code: GAT). It is designed for the approximation or ligation of soft tissue, facilitating precise suture placement during surgical procedures. The device is part of the R Series, which includes accessories to enhance suturing efficiency. Its construction and mechanism align with the regulatory predicate for soft tissue approximation tools, ensuring compatibility with standard surgical practices.

This device is supplied as a reusable medical instrument, intended for use in sterile surgical environments. It is regulated under FDA 510(k) clearance (K040232) and falls under the Special Review classification for General Plastic Surgery applications. The device’s design adheres to regulatory standards for nonabsorbable synthetic sutures, specifically polyethylene-based materials. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality.

Frequently asked questions

What is the Sew-Right SR-5R, Model 020999, used for?

The Sew-Right SR-5R, Model 020999, is a reusable suture placement device designed specifically for approximating or ligating soft tissue during surgical procedures. Its precise mechanism aids in accurate suture placement, which is critical for achieving optimal wound closure and tissue alignment in plastic surgery applications.

Is the Sew-Right SR-5R, Model 020999, single-use or reusable?

This device is intended for reusable use in sterile surgical environments. Like other surgical instruments, it must be properly cleaned, sterilized, and maintained between procedures to ensure safety and functionality. Reusability aligns with standard surgical practices for instruments classified under Product Code GAT.

What type of sutures does the Sew-Right SR-5R, Model 020999, work with?

The Sew-Right SR-5R is designed to work with nonabsorbable, synthetic, polyethylene sutures. Its construction and mechanism are compatible with these materials, adhering to regulatory standards for suture placement tools in soft tissue approximation procedures.

How should the Sew-Right SR-5R, Model 020999, be stored and handled?

Storage and handling of the Sew-Right SR-5R must follow standard surgical instrument protocols to preserve sterility and functionality. This includes proper cleaning, sterilization, and storage in a clean, dry environment away from direct sunlight or extreme temperatures. Adherence to these practices ensures the device remains effective for repeated use.

What regulatory pathway does the Sew-Right SR-5R, Model 020999, follow?

The Sew-Right SR-5R, Model 020999, is regulated under the FDA’s 510(k) clearance pathway, specifically classified under Special Review for General Plastic Surgery applications. It was granted clearance under K040232 and is substantially equivalent to its predicate device, ensuring compliance with regulatory standards for soft tissue approximation tools.

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: Lsi Sew-right R Series Suture Placement Device and Access Product Sew ..., Lsi Sew-right R Series Suture Placement Device and Access Product Sew ..., 510k.innolitics.com, PDF 11. Premarket Notification [510(k)] Summary

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
Lsi Solutions

Sources (1)

  • FDA 510(k) K040232 24 fields · synced Oct 1, 2026