System, Ablation, Ultrasound And Accessories
The Ultrasound Ablation System and Accessories is a surgical tool intended for the coagulation and ablation of soft tissue using high-intensity focused ultrasound energy, distinguishing it from electrosurgical devices and from tissue-cutting instruments. It does not cut tissue but rather delivers ultrasound energy for coagulation and ablation purposes. This is an FDA Class 2 device regulated under 21 CFR 878.4400 in the General and Plastic Surgery specialty, with product code NTB, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NTB
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | Jan 13, 2016 | Substantially Equivalent | Acoustic Medsystems, Inc. |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | Jul 09, 2008 | Substantially Equivalent | Misonix, Inc. |
| K060346 | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | Dec 22, 2006 | Substantially Equivalent | Ultrazonix Dnt AB |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | Jan 26, 2006 | Substantially Equivalent | Misonix, Inc. |
| 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 | May 05, 2004 | Substantially Equivalent | Epicor Medical, Inc. |
| K022894 | EPICOR MEDICAL ABLATION SYSTEM | Feb 26, 2004 | Substantially Equivalent | Epicor Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.