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. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K170294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FTL - Mesh, Surgical, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |