K211458 is an FDA 510(k) clearance for the Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Ningbo Verykind Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on December 30, 2021, 233 days after receiving the submission on May 11, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K211458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2021 |
| Decision Date | December 30, 2021 |
| Days to Decision | 233 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 |