EMPRINT ABLATION SYSTEM— 510(k) K133821
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K133821 for EMPRINT ABLATION SYSTEM, Substantially Equivalent on 2014-04-28. 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
- Traditional
- Location
- Mansfield, MA, 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 K133821
K-number listed on FDA's recall record- Z-0556-2018 — Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
- Z-0557-2018 — Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
- Z-0558-2018 — Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
- Z-0559-2018 — Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
- Z-0560-2018 — Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
- Z-0561-2018 — Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
- Z-1187-2016 — Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133821.
Data sourced from openFDA. This site is unofficial and independent of the FDA.