Signia Small Diameter Reloads Including Regular (Round) Tip Version— 510(k) K222641
Substantially EquivalentCovidien
FDA 510(k) clearance K222641 for Signia Small Diameter Reloads Including Regular (Round) Tip Version, Substantially Equivalent on 2022-11-29. 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
- Traditional
- 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 K222641
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 K222641.
Data sourced from openFDA. This site is unofficial and independent of the FDA.