510(k) K121218
K121218 is an FDA 510(k) premarket notification submitted by Andrew Technologies, LLC for the device "HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,". The FDA issued a decision of Substantially Equivalent on Dec 13, 2012. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Andrew Technologies, LLC has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2012
- Date Received
- Apr 23, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Suction, Lipoplasty For Removal
- Device Class
- Class II
- Regulation Number
- 878.5040
- Review Panel
- SU
- Submission Type
- 510(k)
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring