Signia Stapler— 510(k) K160176
Substantially EquivalentCovidien
FDA 510(k) clearance K160176 for Signia Stapler, Substantially Equivalent on 2016-04-26. 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
Recent devices under product code GDW
view allMore clearances from Covidien
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 →
Recalls naming K160176
K-number listed on FDA's recall record- Z-1228-2023 — Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Z-1825-2019 — EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- Z-1826-2019 — EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- Z-1827-2019 — EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Z-1828-2019 — EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
- Z-1829-2019 — EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
- Z-1830-2019 — EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- Z-1831-2019 — EGIA45 CT AR MD THK REL, EGIA45CTAMT
- Z-1832-2019 — SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
- Z-1833-2019 — SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Z-1834-2019 — SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
- Z-1835-2019 — SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
- Z-1836-2019 — SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
- Z-1237-2018 — Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160176.
Data sourced from openFDA. This site is unofficial and independent of the FDA.