K160900 is an FDA 510(k) clearance for the CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on May 31, 2016, 60 days after receiving the submission on April 1, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K160900 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2016 |
| Decision Date | May 31, 2016 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |