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SyntrFuge System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203800

by Syntr Health Technologies, Inc.

Identifiers

510(k) Number
K203800 FDA 510(k)
FDA Product Code
MUU FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5040 FDA 510(k)
Regulation Number
878.5040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SyntrFuge System is a system, suction, lipoplasty device intended for general and plastic surgery applications. It is an automated fat processing system designed to produce autologous microfat.

The device is supplied as a reusable system and has received FDA 510(k) clearance under K203800. It is used in clinical settings for processing adipose tissue and meets biocompatibility requirements per ISO 10993-1:2018.

Frequently asked questions

What is the SyntrFuge System used for?

The SyntrFuge System is intended for general and plastic surgery applications as an automated fat processing system designed to produce autologous microfat from adipose tissue in clinical settings.

Is the SyntrFuge System reusable or single-use?

The SyntrFuge System is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and reprocessing between procedures.

What regulatory clearance does the SyntrFuge System have?

The SyntrFuge System has received FDA 510(k) clearance under submission number K203800, indicating it is substantially equivalent to a legally marketed predicate device.

What biocompatibility standard does the SyntrFuge System meet?

The SyntrFuge System meets biocompatibility requirements per ISO 10993-1:2018, ensuring it is safe for contact with human tissue during clinical use.

What type of device is the SyntrFuge System classified as?

The SyntrFuge System is classified as a System, Suction, Lipoplasty device under FDA product code MUU and regulation number 878.5040, falling under Class II medical devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SyntrFuge System | Syntr Health, Syntr | The World's Only Automated Fat Processing System: Home, BK220723 - Syntrfuge System | FDA, BK220723 Documents - U.S. Food and Drug Administration, Syntr Health Technologies Announces FDA Clearance of the SyntrFuge ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Syntr Health Technologies, Inc.

Sources (1)

  • FDA 510(k) K203800 24 fields · synced Sep 26, 2026