Emprint Ablation System— 510(k) K163105
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K163105 for Emprint Ablation System, Substantially Equivalent on 2016-12-06. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Code NEY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boulder, CO, US
Recent devices under product code NEY
view all- K252632 — Microwave Ablation Device
- K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
- K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS)
- K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A)
- K241825 — Microwave Ablation Antennas
More clearances from Covidien, LLC
view all- K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT) +1 more
- K253984 — Instrument Exit Point on Touch Surgery Aide
- K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN)
- K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula +4 more
Adverse events under product code NEY
product code NEY- Death
- 24
- Injury
- 388
- Malfunction
- 462
- Other
- 1
- Total
- 875
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 K163105
K-number listed on FDA's recall record- Z-0625-2019 — Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
- Z-0626-2019 — Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
- Z-0627-2019 — Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163105.
Data sourced from openFDA. This site is unofficial and independent of the FDA.