FDA product code NTB: System, Ablation, Ultrasound And Accessories
NTB is the FDA product code for system, ablation, ultrasound and accessories. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under NTB, from 4 different applicants. The average 510(k) review took 384 days (median 424).
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Ablation, Ultrasound And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NTB clearance
Top NTB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Misonix, Inc. | 2 | 2008-07-09 |
| Epicor Medical, Inc. | 2 | 2004-05-05 |
| Acoustic Medsystems, Inc. | 1 | 2016-01-13 |
| Ultrazonix Dnt AB | 1 | 2006-12-22 |
Most recent NTB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150019 | Acoustic Medsystems, Inc. | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | 2016-01-13 | 373 |
| K070779 | Misonix, Inc. | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | 2008-07-09 | 476 |
| K060346 | Ultrazonix Dnt AB | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | 2006-12-22 | 315 |
| K042096 | Misonix, Inc. | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | 2006-01-26 | 540 |
| K040641 | Epicor Medical, Inc. | ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 | 2004-05-05 | 56 |
Recalls for NTB devices
openFDA lists no recalls for product code NTB.
Frequently asked questions
What is FDA product code NTB?
NTB is the FDA product code for system, ablation, ultrasound and accessories. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is NTB?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTB?
Across 6 cleared submissions the average was 384 days from receipt to decision (median 424).
Which companies have the most NTB clearances?
Misonix, Inc. (2); Epicor Medical, Inc. (2); Acoustic Medsystems, Inc. (1); Ultrazonix Dnt AB (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NTB
- Run a recall and safety report across every NTB manufacturer
- Watch product code NTB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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