Home / 510(k) Clearances / K222388

510(k) K222388

swiftPro System by Emblation , Ltd. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2023
Date Received
August 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Emblation , Ltd.

  • K181941 — Swift System (October 18, 2018)

Other clearances for product code NEY

  • K252632 — Microwave Ablation Device (March 2, 2026)
  • K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II (March 2, 2026)
  • K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS) (August 8, 2025)
  • K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A) (September 26, 2024)
  • K241825 — Microwave Ablation Antennas (September 20, 2024)
  • K240480 — IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave (July 19, 2024)
  • K240784 — Temperature Sensor Probe (ABL-18TP20) (May 29, 2024)
  • K240518 — swiftPro™ System (April 23, 2024)
  • K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name); Empr (March 28, 2024)
  • K233140 — Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact (January 31, 2024)