Suture Placement Device and Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K981531 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a suture placement device and accessories, classified under product code GCJ (Gastroenterology/Urology). It is designed to facilitate precise suture placement during surgical procedures, enabling clinicians to approximate soft tissues and prosthetic materials with enhanced control and visualization. The system includes manual instruments tailored for suturing applications, supporting various stitching techniques such as running sutures. Its design aims to minimize needle exposure and improve surgical precision in controlled environments.
The Suture Placement Device and Accessories are manual surgical instruments supplied as a kit, intended for single-use in operating rooms or procedural settings. They are not sterile at the time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The device is FDA-cleared under 510(k) number K981531, with a decision classification of Substantially Equivalent (SESE) through the Gastroenterology/Urology advisory committee. Available sizes and configurations are specified in the accompanying technical documentation, and proper storage follows manufacturer guidelines to maintain device integrity.
Frequently asked questions
What is the Suture Placement Device and Accessories designed for?
This device is engineered to assist clinicians in achieving precise suture placement during surgical procedures. It supports techniques like running sutures and is tailored for approximating soft tissues and prosthetic materials. The design reduces needle exposure and enhances control and visualization, making it ideal for controlled environments such as operating rooms or procedural settings.
How is the Suture Placement Device and Accessories supplied, and is it sterile?
The device is supplied as a manual surgical instrument kit, intended for single-use. It is not sterile at the time of shipment and must be sterilized prior to use, following standard medical device sterilization protocols to ensure safety and efficacy.
What types of suturing techniques does this device support?
The kit is specifically designed to support running sutures, a common technique for closing wounds or securing tissues. Its manual instruments provide enhanced precision and control, reducing the risk of complications associated with needle exposure during suturing.
Are there different sizes or configurations available?
Yes, the device comes in various sizes and configurations, though the exact specifications are detailed in the accompanying technical documentation. These variations allow clinicians to select the appropriate tool based on the surgical procedure and tissue type being addressed.
How should the device be stored to maintain its integrity?
Proper storage follows manufacturer guidelines to preserve the device’s functionality and sterility (once sterilized). The kit should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, and protected from physical damage or contamination until ready for 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. Sources consulted: Surgical suture - Wikipedia, C1® | Lsi Solutions®, LSI Surgical Products - LSI Solutions, Suture Placement Device and Accessories, Flexible Suture Placement ..., Lsi Solutions Flexible Suture Placement Device and Accessories Product ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981531 | Class II | Active |
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Manufacturer
- Manufacturer
- Lsi Solutions
Sources (1)
- FDA 510(k) K981531 24 fields · synced Oct 1, 2026