K100386 is an FDA 510(k) clearance for the DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Changzhou Waston Medical Appliance Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 1, 2010, 13 days after receiving the submission on February 16, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K100386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2010 |
| Decision Date | March 01, 2010 |
| Days to Decision | 13 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 |