K022894 is an FDA 510(k) clearance for the EPICOR MEDICAL ABLATION SYSTEM. This device is classified as a System, Ablation, Ultrasound And Accessories (Class II - Special Controls, product code NTB).
Submitted by Epicor Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 26, 2004, 541 days after receiving the submission on September 3, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. 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..
| 510(k) Number | K022894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2002 |
| Decision Date | February 26, 2004 |
| Days to Decision | 541 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NTB — System, Ablation, Ultrasound And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| 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. |