K163142 is an FDA 510(k) clearance for the SpeedStitch Suture Passer. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by ArthroCare Corporation (Irvine, US). The FDA issued a Cleared decision on January 6, 2017, 58 days after receiving the submission on November 9, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K163142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2016 |
| Decision Date | January 06, 2017 |
| Days to Decision | 58 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT — Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |