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FDA 510(k)

SyntrFuge System

K-Number: K203800 · 2021-07-02

ApplicantSyntr Health Technologies, Inc.
Decision Date2021-07-02
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SyntrFuge System is the device name listed in this FDA 510(k) record. The listed applicant is Syntr Health Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K203800. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SyntrFuge System?

SyntrFuge System is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Syntr Health Technologies, Inc.. The 510(k) number is K203800.

When did SyntrFuge System receive FDA 510(k) clearance?

SyntrFuge System received FDA 510(k) clearance on 2021-07-02, under 510(k) number K203800.

Who is the listed applicant for SyntrFuge System?

The FDA 510(k) record lists Syntr Health Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SyntrFuge System?

The FDA product code for SyntrFuge System is MUU.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05519501Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot UlcersNOT_YET_RECRUITINGNCT05522426Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat GraftingNOT_YET_RECRUITINGNCT05526898Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee OsteoarthritisNOT_YET_RECRUITING

Related Devices (Code: MUU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) KitMillennium Medical Technologies Inc (Dba Cellmyx)K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell CorporationK193363Dermapose RefreshPuregraft, LLCK182732JTL-250-01Jointechlabs, Inc.K191564Progenikine Concentrating System 25 mL SystemEmcyte Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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