ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1
FDA 510(k) clearance K040641 · decided 2004-05-05
Clearance details
- K-number
- K040641
- Device name
- ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1
- Applicant
- Epicor Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-10
- Decision date
- 2004-05-05
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- NTB
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| EPICOR MEDICAL ABLATION SYSTEM (K022894) | Epicor Medical, Inc. | 2004-02-26 |
Recalls involving this device
No recalls on record reference this clearance.