K150882 is an FDA 510(k) clearance for the Edwards Suture Fastening System. This device is classified as a Instrument, Ligature Passing And Knot Tying (Class I - General Controls, product code HCF).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 16, 2015, 75 days after receiving the submission on April 2, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K150882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2015 |
| Decision Date | June 16, 2015 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HCF — Instrument, Ligature Passing And Knot Tying |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |