K010666 is an FDA 510(k) clearance for the XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE. This device is classified as a System, Suction, Lipoplasty For Removal (Class II - Special Controls, product code QPB).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 7, 2001, 62 days after receiving the submission on March 6, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5040. A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring.
| 510(k) Number | K010666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2001 |
| Decision Date | May 07, 2001 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QPB — System, Suction, Lipoplasty For Removal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5040 |
| Definition | A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring |