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FDA 510(k)

REVOLVE ENVI 600 Advanced Adipose System

K-Number: K193539 · 2020-05-28

ApplicantLifecell Corporation
Decision Date2020-05-28
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REVOLVE ENVI 600 Advanced Adipose System is a medical device manufactured by Lifecell Corporation. It received FDA 510(k) clearance on 2020-05-28 under approval number K193539. 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 REVOLVE ENVI 600 Advanced Adipose System?

REVOLVE ENVI 600 Advanced Adipose System is a medical device that received FDA 510(k) clearance on 2020-05-28. It is manufactured by Lifecell Corporation. The 510(k) number is K193539.

When was REVOLVE ENVI 600 Advanced Adipose System approved by the FDA?

REVOLVE ENVI 600 Advanced Adipose System received FDA 510(k) clearance on 2020-05-28, under approval number K193539.

What company makes REVOLVE ENVI 600 Advanced Adipose System?

REVOLVE ENVI 600 Advanced Adipose System is manufactured by Lifecell Corporation.

What is the FDA product code for REVOLVE ENVI 600 Advanced Adipose System?

The FDA product code for REVOLVE ENVI 600 Advanced Adipose System is MUU.

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Related PubMed Literature

PMID: 40069892 Enhanced mitochondrial function and delivery from adipose-derived stem cell spheres via the EZH2-H3K27me3-PPARγ pathway for advanced therapy. Stem cell research & therapy (2025)

Other Devices by Lifecell Corporation

K163647Revolve Envi 600 Advanced Adipose System K162752ARTIA Reconstructive Tissue Matrix Perforated

Related Devices (Code: MUU)

K161636Lipogems SystemLipogems International Spa K172714LipiVageGenesis Biosystems, Inc. K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation K171242Alma LipoFlow SystemAlma Lasers, Inc. K171135Lipogems SystemLipogems International Spa K170449Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protectionMillennium Medical Technologies, Inc.

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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