510(k) K231934
K231934 is an FDA 510(k) premarket notification submitted by Covidien for the device "GIA Stapler with Tri-Staple Technology". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. Covidien has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2023
- Date Received
- June 30, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stapler, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4740
- Review Panel
- SU
- Submission Type
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.