Home / 510(k) Clearances / K241827

510(k) K241827

Microwave Ablation Generator (KY-2000A, KY-2100A) by Canyon Medical, Inc. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2024
Date Received
June 24, 2024
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 Canyon Medical, Inc.

  • K250209 — Polyvinyl Alcohol Embolic Microspheres (September 23, 2025)
  • K241825 — Microwave Ablation Antennas (September 20, 2024)
  • K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-a (January 17, 2024)
  • K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-A (April 3, 2023)

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)
  • 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)
  • K231738 — NEUWAVE™ Microwave Ablation System and Accessories (November 16, 2023)