Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Revolve Envi 600 Advanced Adipose System

K-Number: K163647 · 2017-08-25

ApplicantLifecell Corporation
Decision Date2017-08-25
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 2017-08-25 under approval number K163647. 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 2017-08-25. It is manufactured by Lifecell Corporation. The 510(k) number is K163647.

When was Revolve Envi 600 Advanced Adipose System approved by the FDA?

Revolve Envi 600 Advanced Adipose System received FDA 510(k) clearance on 2017-08-25, under approval number K163647.

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.

Related Clinical Trials

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING NCT06689553 Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure TERMINATED NCT07224464 The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia. RECRUITING NCT07538115 Advanced vs Standard Hemodynamic Monitoring During Propofol Sedation for ERCP: A Prospective Study RECRUITING NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

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

K162752ARTIA Reconstructive Tissue Matrix Perforated K193539REVOLVE ENVI 600 Advanced Adipose System

Related Devices (Code: MUU)

K161636Lipogems SystemLipogems International Spa K172714LipiVageGenesis Biosystems, Inc. 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. K161372The Red Head Collection Device, The Jordy Connection SystemMiami Fat Supply

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.

↑