K142808 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 March 9, 2015, 161 days after receiving the submission on September 29, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K142808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2014 |
| Decision Date | March 09, 2015 |
| Days to Decision | 161 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 |