Cleared Traditional

VITRUVIAN ULTIMATE ASPIRATOR

K161722 · Black & Black Surgical, Inc. · General & Plastic Surgery

Jul 2016

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K161722 is an FDA 510(k) clearance for the VITRUVIAN ULTIMATE ASPIRATOR, a System, Suction, Lipoplasty For Removal (Class II — Special Controls, product code QPB), submitted by Black & Black Surgical, Inc. (Tucker, US). The FDA issued a Cleared decision on July 26, 2016, 34 days after receiving the submission on June 22, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.

Submission Details

510(k) Number	K161722 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2016
Decision Date	July 26, 2016
Days to Decision	34 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	QPB — System, Suction, Lipoplasty For Removal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5040
Definition	A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring