Cleared Traditional

VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5?) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4?x 6?) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6?) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6?x8?) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6?x10?) Oval

K170294 · C. R. Bard · General & Plastic Surgery

May 2017

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K170294 is an FDA 510(k) clearance for the VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5?) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4?x 6?) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6?) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6?x8?) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6?x10?) Oval, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by C. R. Bard (Warwick, US). The FDA issued a Cleared decision on May 1, 2017, 90 days after receiving the submission on January 31, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K170294 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2017
Decision Date	May 01, 2017
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF