K181657 is an FDA 510(k) clearance for the easyLCTM Linear Cutter Staplers and Loading Units fot Single Use. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Ezisurg Medical Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 1, 2019, 224 days after receiving the submission on June 22, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K181657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2018 |
| Decision Date | February 01, 2019 |
| Days to Decision | 224 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 |