K142656 is an FDA 510(k) clearance for the Surgical Gut Suture. This device is classified as a Suture, Absorbable, Natural (Class II - Special Controls, product code GAL).
Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on January 29, 2015, 133 days after receiving the submission on September 18, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K142656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2014 |
| Decision Date | January 29, 2015 |
| Days to Decision | 133 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAL — Suture, Absorbable, Natural |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4830 |