510(k) K253657
K253657 is an FDA 510(k) premarket notification submitted by Covidien (Part of Medtronic) for the device "Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Covidien (Part of Medtronic) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2026
- Date Received
- November 20, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type