Cleared Traditional

VITRUVIAN INFILTRATION PUMP

K170629 · Black & Black Surgical, Inc. · General & Plastic Surgery

Jun 2017

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K170629 is an FDA 510(k) clearance for the VITRUVIAN INFILTRATION PUMP, 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 June 22, 2017, 112 days after receiving the submission on March 2, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.

Submission Details

510(k) Number	K170629 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2017
Decision Date	June 22, 2017
Days to Decision	112 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