# NTB: System, Ablation, Ultrasound And Accessories

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 2
- 2006: 2
- 2008: 1
- 2016: 1

## Most-cited predicates
- 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 (2004), cited by 3
- K022894: Epicor Medical Ablation System (2004), cited by 2
- K042096: Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System (2006), cited by 1
- K070779: Sonatherm 600I Ultrasonic Lesion Generating System (2008), cited by 1

Source page: https://510kreport.com/product-code/NTB
Data by year (CSV): https://510kreport.com/product-code/NTB.csv