Product code NTB

Device name: System, Ablation, Ultrasound And Accessories
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.4400
Review panel: SU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Definition: 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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K150019	TheraVision Ultrasound Ablation System and ACOUSTx Applicators	Acoustic Medsystems, Inc.	2016-01-13
K070779	SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM	Misonix, Inc.	2008-07-09
K060346	ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM	Ultrazonix Dnt AB	2006-12-22
K042096	MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM	Misonix, Inc.	2006-01-26
K040641	ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1	Epicor Medical, Inc.	2004-05-05
K022894	EPICOR MEDICAL ABLATION SYSTEM	Epicor Medical, Inc.	2004-02-26

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