EEA Circular Stapler with Tri-Staple Technology— 510(k) K221005
Substantially EquivalentCovidien
FDA 510(k) clearance K221005 for EEA Circular Stapler with Tri-Staple Technology, Substantially Equivalent on 2022-04-29. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shanghai, CN
Recent devices under product code GDW
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view all- K241486 — Sofsilk Coated Braided Silk Suture
- K240077 — Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)
- K231934 — GIA Stapler with Tri-Staple Technology
- K231240 — MaxTack Motorized Fixation Device
- K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
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.