Product code NTB— General, Plastic Surgery
EPICOR MEDICAL ABLATION SYSTEM
- Classification name
- System, Ablation, Ultrasound And Accessories
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 6
- First cleared
- Most recent
FDA classification 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.”
Market context for product code NTB
FDA has cleared devices under product code NTB between 2004 and 2016, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2016
- 2008
- 2006
- 2004
Top applicants under product code NTB
Recent clearances under product code NTB
- K150019 — TheraVision Ultrasound Ablation System and ACOUSTx Applicators
- K070779 — SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
- K060346 — ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM
- K042096 — MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM
- 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
- K022894 — EPICOR MEDICAL ABLATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.