Cleared Traditional

LipoFilter - Hospital Pack, LipoFilter - Clinic Pack

K150779 · Microaire Surgical Instruments, LLC · General & Plastic Surgery

May 2015

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K150779 is an FDA 510(k) clearance for the LipoFilter - Hospital Pack, LipoFilter - Clinic Pack, a System, Suction, Lipoplasty (Class II — Special Controls, product code MUU), submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on May 22, 2015, 58 days after receiving the submission on March 25, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.

Submission Details

510(k) Number	K150779 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2015
Decision Date	May 22, 2015
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	MUU — System, Suction, Lipoplasty
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5040
Definition	See Federal Register Notice At 86 Fr 50887 ?consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article? (frn) (fda-2021-n-0881).