MICROSULIS TISSUE ABLATION SYSTEM

FDA 510(k) clearance K052919 · decided 2006-01-13

Clearance details

K-number: K052919
Device name: MICROSULIS TISSUE ABLATION SYSTEM
Applicant: Microsulis Americas, Inc.
Decision: Substantially Equivalent
Date received: 2005-10-17
Decision date: 2006-01-13
Days to decision: 88 days
Clearance type: Traditional
Product code: NEY
Device class: 2
Regulation number: 878.4400
Medical specialty: General, Plastic Surgery
Advisory committee: General, Plastic Surgery
Location: Waltham, MA, 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.

Record	Firm	Date
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 Limited	2025-08-08
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 Limited	2024-04-23
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.