510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100114Substantially Equivalent

Fat Concentration System

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100114 is the FDA 510(k) clearance record for FAT CONCENTRATION SYSTEM, a class II device, cleared for Biomet, Inc. on under FDA product code MUU (System, Suction, Lipoplasty). FDA's definition for product code MUU reads: "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)". FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K100114.

Clearance record

Decision date
Received
(257 days to decision)
Product code
MUU System, Suction, Lipoplasty
Regulation
21 CFR 878.5040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Biomet, Inc. 56 E. Bell Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUU

Trailing 12 months

FDA records hold no clearances under product code MUU in the trailing twelve months.

FDA records show no clearances under product code MUU in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MUU, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260