VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4x 6) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6x8) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6x10) Oval— 510(k) K170294

Clearance details

Applicant

C. R. Bard

Product code

Code FTL

Device class

Class 2

Regulation

21 CFR 878.3300

Advisory panel

General, Plastic Surgery

Date received

2017-01-31

Decision date

2017-05-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warwick, RI, US

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Death

317

Injury

66,072

Malfunction

1,273

Other

3

Total

67,665

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →