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510(k) K210528

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit by Millennium Medical Technologies Inc (Dba Cellmyx) — Product Code MUU

K210528 is an FDA 510(k) premarket notification submitted by Millennium Medical Technologies Inc (Dba Cellmyx) for the device "IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit". The FDA issued a decision of Substantially Equivalent on March 16, 2022. The device falls under product code MUU (System, Suction, Lipoplasty), a Class II device regulated under 21 CFR 878.5040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2022
Date Received
February 23, 2021
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 for product code MUU

  • 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)
  • K172714 — LipiVage (December 8, 2017)

FDA data resources