Atlas FDA

Emprint Ablation System

FDA 510(k) clearance K163105 · decided 2016-12-06

Clearance details

K-number
K163105
Device name
Emprint Ablation System
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2016-11-07
Decision date
2016-12-06
Days to decision
29 days
Clearance type
Special
Product code
NEY
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Boulder, CO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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) (K253771)Nanjing Devin Medical Technology Co., Ltd.2026-03-02
Microwave Ablation Device (K252632)Nanjing Dewen Medical Technology Co., Ltd.2026-03-02
swiftPro System (SWF-SPS); Swift System (SWF-SYS) (K250718)Emblation Limited2025-08-08
Microwave Ablation Generator (KY-2000A, KY-2100A) (K241827)Canyon Medical, Inc.2024-09-26
Microwave Ablation Antennas (K241825)Canyon Medical, Inc.2024-09-20
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) (K240480)Varian Medical Systems, Inc.2024-07-19
Temperature Sensor Probe (ABL-18TP20) (K240784)Varian Medical Systems, Inc.2024-05-29
swiftPro™ System (K240518)Emblation Limited2024-04-23
Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B) (K233838)Medtronic, Inc.2024-03-28
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) (K233140)Hygea Medical Technology Co., Ltd.2024-01-31
NEUWAVE™ Microwave Ablation System and Accessories (K231738)Neuwave Medical, Inc.2023-11-16
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) (K232241)Betters(Suzhou) Medical Co., Ltd.2023-11-13

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012)Covidien, LLC2005-06-24
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011)Covidien, LLC2005-02-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010)Covidien, LLC2002-11-15
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007)Covidien, LLC2002-04-18