NTB
6 FDA 510(k) clearances · Product code
476 daysmedian time to decision
541 days90th percentile
6clearances measured
FDA profile
- Official device name
- System, Ablation, Ultrasound And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA 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.
- Adverse events (MAUDE)
- 2008: 5 · 2009: 19 · 2010: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TheraVision Ultrasound Ablation System and ACOUSTx Applicators (K150019) | Acoustic Medsystems, Inc. | 2016-01-13 |
| SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (K070779) | Misonix, Inc. | 2008-07-09 |
| ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM (K060346) | Ultrazonix Dnt AB | 2006-12-22 |
| MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM (K042096) | Misonix, Inc. | 2006-01-26 |
| ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 (K040641) | Epicor Medical, Inc. | 2004-05-05 |
| EPICOR MEDICAL ABLATION SYSTEM (K022894) | Epicor Medical, Inc. | 2004-02-26 |
Track NTB automatically
Every clearance here is in the API, with alerts when new ones post.