ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks— 510(k) K151659
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K151659 for ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks, Substantially Equivalent on 2015-07-17. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Product 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.