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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 the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corporation. It received FDA 510(k) clearance on 2020-05-28 under 510(k) 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. The listed applicant is Lifecell Corporation. The 510(k) number is K193539.

When did REVOLVE ENVI 600 Advanced Adipose System receive FDA 510(k) clearance?

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

Who is the listed applicant for REVOLVE ENVI 600 Advanced Adipose System?

The FDA 510(k) record lists Lifecell Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Lifecell Corporation as applicant

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.

K163647Revolve Envi 600 Advanced Adipose SystemK162752ARTIA Reconstructive Tissue Matrix Perforated

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)K203800SyntrFuge SystemSyntr Health Technologies, Inc.K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.K193363Dermapose RefreshPuregraft, LLCK182732JTL-250-01Jointechlabs, Inc.K191564Progenikine Concentrating System 25 mL SystemEmcyte Corporation

Official Source

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

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