510(k) K070779

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

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.

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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)