Home / 510(k) Clearances / K130152

510(k) K130152

HYDRASOLVE LIPOPLASTY SYSTEM by Andrew Technologies, LLC — Product Code MUU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2013
Date Received
January 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

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).

Other clearances by Andrew Technologies, LLC

  • K121218 — HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH (December 13, 2012)
  • K092066 — PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE (April 12, 2010)

Other clearances for product code MUU

  • K210528 — IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Bod (March 16, 2022)
  • K203800 — SyntrFuge System (July 2, 2021)
  • K202443 — Smart Kit Basic, Smart Kit Pro (March 11, 2021)
  • K193539 — REVOLVE ENVI 600 Advanced Adipose System (May 28, 2020)
  • K193363 — Dermapose Refresh (April 14, 2020)
  • K182732 — JTL-250-01 (November 18, 2019)
  • K191564 — Progenikine Concentrating System 25 mL System (November 7, 2019)
  • K190386 — KTA Adipose Treatment Kit (October 10, 2019)
  • K190278 — AuraGen 123 Suction Lipoplasty System (A123) (May 3, 2019)
  • K172717 — Automatic Tissue Processing Unit (May 25, 2018)