ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY— 510(k) K132493
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K132493 for ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY, Substantially Equivalent on 2013-10-23. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Applicant
- Covidien, LLC
- 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
- North Haven, CT, US
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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 →
Recalls naming K132493
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132493.
Data sourced from openFDA. This site is unofficial and independent of the FDA.