510(k) K130152
K130152 is an FDA 510(k) premarket notification submitted by Andrew Technologies, LLC for the device "HYDRASOLVE LIPOPLASTY SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 18, 2013. The device falls under product code MUU (System, Suction, Lipoplasty), 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
- Apr 18, 2013
- Date Received
- Jan 22, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Suction, Lipoplasty
- Device Class
- Class II
- Regulation Number
- 878.5040
- Review Panel
- SU
- Submission Type
- 510(k)
See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).