K253657
Substantially EquivalentTri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads
This filing covers four staple-reload variants for Medtronic's Endo GIA and Signia surgical stapler platforms. Product code GDW covers surgical staplers and reloads; these are the disposable cartridges that load into the powered stapler handpiece during laparoscopic, open, and bariatric procedures.
General, Plastic Surgery panel (despite the cross-specialty use — GDW is assigned there), Traditional 510(k). Reload filings are the highest-volume corner of GDW because each new tissue-thickness or staple-line variant typically warrants its own clearance. This is a portfolio refresh rather than a novel device.
Filed by Covidien (Part of Medtronic) from North Haven, CT. Five-month clock — fast for GDW, likely because the predicate device comparisons are mechanical and well-characterized.
- Applicant
- Covidien (Part of Medtronic)
- Product code
- GDW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Haven, CT, US
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.