FDA Product Code
FDA Product Code NTB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | Acoustic Medsystems, Inc. | 2016-01-13 | Traditional | PDF ↗ |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | 2008-07-09 | Traditional | PDF ↗ |
| K060346 | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | Ultrazonix Dnt AB | 2006-12-22 | Traditional | PDF ↗ |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | 2006-01-26 | Traditional | PDF ↗ |
| 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 | Epicor Medical, Inc. | 2004-05-05 | Traditional | PDF ↗ |
| K022894 | EPICOR MEDICAL ABLATION SYSTEM | Epicor Medical, Inc. | 2004-02-26 | Traditional | PDF ↗ |
Product code NTB · Class II · General, Plastic Surgery. Data: openFDA.