510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191564Substantially Equivalent

Progenikine Concentrating System 25 mL System

EmCyte Corporation, Fort Meyers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K191564 is the FDA 510(k) clearance record for Progenikine Concentrating System 25 mL System, a class II device, cleared for Emcyte Corporation 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 2 510(k) clearances for Emcyte Corporation, from to . As of , FDA records show no recalls naming K191564.

Clearance record

Decision date
Received
(147 days to decision)
Product code
MUU System, Suction, Lipoplasty
Regulation
21 CFR 878.5040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Emcyte Corporation 4331 Veronica S. Shoemaker Blvd., Suite 4, Fort Meyers FL
510(k) summary
Statement
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MUU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260