System, Ablation, Ultrasound And Accessories

Product Code: NTB

General & Plastic Surgery Ultrasonic Medical Devices (Miscellaneous)

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.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4400


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as NTB

5782System, Ablation, Ultrasound And AccessoriesElectrosurgical Cutting And Coagulation Device And Accessories.

Total Product Life Cycle (TPLC) Devices

5782System, Ablation, Ultrasound And AccessoriesElectrosurgical Cutting And Coagulation Device And Accessories.

FDA Consensus Standards

System, Ablation, Ultrasound And Accessories [32415]21 CFR §878.4400 🔎

Pre-market Notifications for NTB

K150019TheraVision Ultrasound Ablation System And ACOUSTx ApplicatorsACOUSTIC MEDSYSTEMS, INC.
K070779SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEMMISONIX, INC.
K060346ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEMULTRAZONIX DNT AB
K042096MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEMMISONIX, INC.
K040641ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1EPICOR MEDICAL, INC.
K022894EPICOR MEDICAL ABLATION SYSTEMEPICOR MEDICAL, INC.

Maude Adverse Events

ULTRACINCH LP, 10 CELL, UC-LP-10ST. JUDE MEDICAL2012-07-10
ULTRACINCH LP, 10 CELL, UC-LP-10ST. JUDE MEDICAL2012-07-10
ULTRAWAND LPST. JUDE MEDICAL2010-12-27
ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, UC-LP-9ST. JUDE MEDICAL2010-11-10
EPICOR ULTRACINCH LP ABLATION DEVICEST. JUDE MEDICAL2010-09-15
ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, 11 CELLST. JUDE MEDICAL2010-03-26
ABLATION CONTROL SYSTEMST. JUDE MEDICAL2010-03-08
ULTRAWAND LPST. JUDE MEDICAL2009-11-25
ULTRACINCH LP, 10 CELL, UC-LP-10ST. JUDE MEDICAL2009-11-20
ULTRAWAND LPST. JUDE MEDICAL2009-11-09
ULTRACINCH DEPLOYABLE TISSUE ABLATION, UC-13ST. JUDE MEDICAL2009-11-06
ULTRAWAND LPST. JUDE MEDICAL2009-11-04
ULTRAWAND LPST. JUDE MEDICAL2009-11-04
ULTRAWAND LPST. JUDE MEDICAL2009-11-04
ULTRAWAND LPST. JUDE MEDICAL2009-11-04
ULTRACINCH LP, 10 CELL, UC-LP-10ST. JUDE MEDICAL2009-09-02
ULTRACINCH LPST. JUDE MEDICAL, INC2009-08-31
ULTRACINCH LP, 10 CELL, UC-LP-10ST. JUDE MEDICAL2009-08-28
ULTRAWAND LPST. JUDE MEDICAL2009-07-27
ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, 11 CELLST. JUDE MEDICAL2009-06-15
ULTRAWAND LPST. JUDE MEDICAL2009-06-15
ULTRAWAND LPST. JUDE MEDICAL2009-06-10
ULTRAWAND LPST. JUDE MEDICAL, INC.2009-05-27
ULTRAWAND LPST. JUDE MEDICAL2009-04-24
ULTRACINCH DEPLOYABLE TISSUE ABLATION UC-11ST. JUDE MEDICAL2009-04-21
ULTRAWAND LPST. JUDE MEDICAL2009-03-19
ULTRAWAND HARMONIZED, UW-2, COMMERCIAL MOLD HANDLEST. JUDE MEDICAL2008-10-20
ULTRACINCH ACCESSORY KIT, UC-ACC-1EPICOR MEDICAL, INC.2008-10-09
ULTRACINCH DEPLOYABLE TISSUE ABLATION , UC-8EPICOR MEDICAL INC.2008-06-12
ULTRACINCH DEPLOYABLE TISSUE ABLATION UC-11EPICOR MEDICAL, INC.2008-02-04
ULTRACINCH DEPLOYABLE TISSUE ABLATION UC-11EPICOR MEDICAL, INC2008-01-09
ULTRACINCH DEPLOYABLE TISSUE ABLATION DEVICEEPICOR MEDICAL, INC.2007-08-08
ULTRACINCH ACCESSORY KIT, UC-ACC-1EPICOR MEDICAL, INC.2007-06-11
ULTRACINCH ACCESSORY KIT, UC-ACC-1EPICOR MEDICAL, INC.2005-05-05
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