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510(k) K070779

SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM by Misonix, Inc. — Product Code NTB

K070779 is an FDA 510(k) premarket notification submitted by Misonix, Inc. for the device "SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 2008. The device falls under product code NTB (System, Ablation, Ultrasound And Accessories), a Class II device regulated under 21 CFR 878.4400. Misonix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2008
Date Received
March 21, 2007
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 Misonix, Inc.

  • K221235 — neXus Ultrasonic Surgical Aspirator System (July 28, 2022)
  • K212060 — neXus Ultrasonic Surgical Aspirator System (December 13, 2021)
  • K190160 — neXus Ultrasonic Surgical Aspirator System (May 30, 2019)
  • K123980 — SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES (March 5, 2013)
  • K112782 — MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES (December 1, 2011)
  • K070313 — MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (May 11, 2007)
  • K062471 — ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF (October 26, 2006)
  • K042096 — MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM (January 26, 2006)
  • K052702 — MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY (November 21, 2005)
  • K050776 — AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (June 6, 2005)

Other clearances for product code NTB

  • K150019 — TheraVision Ultrasound Ablation System and ACOUSTx Applicators (January 13, 2016)
  • 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)
  • K022894 — EPICOR MEDICAL ABLATION SYSTEM (February 26, 2004)

FDA data resources