GIA Stapler with Tri-Staple Technology
FDA 510(k)Class II (US FDA 510(k))
by Covidien
Identifiers
- 510(k) Number
- K231934 FDA 510(k)
- FDA Product Code
- GAG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4740 FDA 510(k)
- Regulation Number
- 878.4740 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The GIA Stapler with Tri-Staple Technology is a surgical stapler designed for open procedures. It is classified as a Class II medical device and used to approximate and occlude tissue by applying staples in a linear fashion. This device features a three-row stapling mechanism, providing enhanced tissue compression and sealing capabilities compared to traditional two-row staplers.
This device is intended for single-use in surgical settings and is supplied sterile. It is not MRI-safe and must be handled according to manufacturer guidelines. Available in multiple model variants (e.g., GIA60MTS), it requires proper storage to maintain sterility and functionality. The device holds an FDA 510(k) clearance under the classification code 878.4740, ensuring compliance with regulatory standards for surgical staplers.
Frequently asked questions
What is the GIA Stapler with Tri-Staple Technology used for?
The GIA Stapler with Tri-Staple Technology is designed for open surgical procedures to approximate and occlude tissue. Its three-row stapling mechanism provides enhanced tissue compression and sealing compared to traditional two-row staplers, ensuring better closure of tissue layers during surgery.
How is the GIA Stapler with Tri-Staple Technology supplied and what are its sterility and usage guidelines?
The device is supplied sterile and intended for single-use only. It must be handled according to the manufacturer’s guidelines to maintain sterility and functionality. Since it is not MRI-safe, proper storage and handling are critical to avoid contamination or damage.
What model variants are available for the GIA Stapler with Tri-Staple Technology?
The GIA Stapler with Tri-Staple Technology is available in multiple model variants, such as the GIA60MTS. These variants may differ in specifications like staple length or firing mechanism, so verifying the exact model ensures compatibility with surgical needs.
How should the GIA Stapler with Tri-Staple Technology be stored to preserve sterility?
The device must be stored in its original packaging until ready for use to maintain sterility. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s storage instructions to ensure the device remains functional and safe for use.
What regulatory clearance does the GIA Stapler with Tri-Staple Technology hold?
The GIA Stapler with Tri-Staple Technology holds FDA 510(k) clearance under the classification code 878.4740. This clearance confirms that the device meets regulatory standards for surgical staplers and is classified as a Class II medical device.
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: GIA™ stapler with Tri-Staple™ technology - Medtronic, GIA60MTS | Medtronic, GIA™ stapler with Tri-Staple™ technology | Medtronic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231934 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien
Sources (1)
- FDA 510(k) K231934 24 fields · synced Oct 1, 2026