Signia Small Diameter Reloads— 510(k) K191070
Substantially EquivalentCovidien
FDA 510(k) clearance K191070 for Signia Small Diameter Reloads, Substantially Equivalent on 2019-09-04. 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 K191070
K-number listed on FDA's recall record- Z-0485-2026 — Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
- Z-0486-2026 — Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
- Z-1457-2024 — Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
- Z-1458-2024 — Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
- Z-1383-2021 — Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
- Z-1384-2021 — Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
- Z-1385-2021 — Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191070.
Data sourced from openFDA. This site is unofficial and independent of the FDA.