DeviceClearance

Product code MUU— General, Plastic Surgery

Lipogems System

Classification name
System, Suction, Lipoplasty
Device class
Class 2
Regulation
21 CFR 878.5040
Advisory panel
General, Plastic Surgery
Total cleared
40
First cleared
Most recent

FDA classification definition

“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).”

— U.S. Food and Drug Administration, device classification record for product code MUU under 21 CFR 878.5040, via openFDA

Market context for product code MUU

FDA has cleared 40 devices under product code MUU between 2007 and 2022, filed by 30 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MUU

Recent clearances under product code MUU

Data sourced from openFDA. This site is unofficial and independent of the FDA.