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510(k) K022894

EPICOR MEDICAL ABLATION SYSTEM by Epicor Medical, Inc. — Product Code NTB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2004
Date Received
September 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.

Other clearances by Epicor Medical, Inc.

  • K040641 — ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, (May 5, 2004)

Other clearances for product code NTB

  • K150019 — TheraVision Ultrasound Ablation System and ACOUSTx Applicators (January 13, 2016)
  • K070779 — SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (July 9, 2008)
  • K060346 — ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM (December 22, 2006)
  • K042096 — MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM (January 26, 2006)
  • K040641 — ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, (May 5, 2004)